Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-04 @ 5:47 AM
Study NCT ID:
NCT00377260
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2006-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acute Otitis Media (AOM) Therapy Trial in Young Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}], 'ancestors': [{'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Hoberman@chp.edu', 'phone': '412-692-5249', 'title': 'Efficacy of Antimicrobials in Young children with Acute Otitis Media', 'organization': "Children's Hospital of Pittsburgh of UPMC"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Long-term implications of abnormal otoscopic findings (bulging) without symptoms, and persistent middle-ear effusion without findings of acute inflammation as forerunners of subsequent acute otitis media episodes remains uncertain.'}}, 'adverseEventsModule': {'timeFrame': 'We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.', 'description': 'A condition present at enrollment was recorded in the Review of Systems, not as an Adverse Event. However, if this condition worsened or developed after the enrollment visit, we reported this as an Adverse Event.', 'eventGroups': [{'id': 'EG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.', 'otherNumAtRisk': 144, 'otherNumAffected': 117, 'seriousNumAtRisk': 144, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.', 'otherNumAtRisk': 147, 'otherNumAffected': 104, 'seriousNumAtRisk': 147, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Asthma or wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Diaper dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 91, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 64, 'numAffected': 57}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Oral thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Protocol defined diarrhea', 'notes': 'This is defined as 3 watery stools in 1 day or 2 watery stools for each of 2 consecutive days.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 40, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 36, 'numAffected': 34}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Viral exanthem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Viral illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}], 'seriousEvents': [{'term': 'Mastoiditis', 'notes': 'One child was diagnosed with an early mastoiditis at the on-therapy visit. Middle ear culture yielded serotype 19A S. pneumoniae. The child was hospitalized and recovered uneventfully.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Pneumonia', 'notes': 'One child developed pneumonia on study day three. The child was hospitalized and recovered uneventfully. After discharge the mother withdrew from the study. She felt it was too burdensome to complete the memory aid and come for follow-up visits.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'The Distribution of Clinical Failures by the On-therapy Visit According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Clinical failures by the on therapy visit', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Subjects not classified as clinical failures', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< .001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of clinical treatment failures by the on-therapy visit.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'On-therapy visit. The mean day for this visit was 5.0.', 'description': 'Clinical failure by the on-therapy visit is defined as either failure to achieve substantial improvement in symptoms, or worsening of otoscopic signs, or both.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children followed at least 72 hours after the initial dose of study medication plus the number of children meeting the criteria for clinical failure less than 72 hours after the initial dose of study medication.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Clinical Failures by the End-of-therapy Visit According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Clinical failures by the end of therapy visit', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Subjects not classified as clinical failures', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< .001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of clinical failures by the end of therapy.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End-of-therapy visit. The mean day for this visit was 11.6.', 'description': 'Clinical failure by the end of therapy visit is defined as failure to achieve complete or virtually complete resolution of symptoms and of otoscopic signs, but without regard to the persistence of middle ear effusion.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children evaluated post therapy plus the number of children who met the criteria for clinical failure prior to the end of therapy.'}, {'type': 'SECONDARY', 'title': 'The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Day 1 PM', 'categories': [{'measurements': [{'value': '5.80', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '6.20', 'spread': '3.33', 'groupId': 'OG001'}]}]}, {'title': 'Day 2 AM', 'categories': [{'measurements': [{'value': '4.12', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '4.85', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 2 PM', 'categories': [{'measurements': [{'value': '3.78', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '4.33', 'spread': '3.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 3 AM', 'categories': [{'measurements': [{'value': '2.86', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '3.37', 'spread': '3.04', 'groupId': 'OG001'}]}]}, {'title': 'Day 3 PM', 'categories': [{'measurements': [{'value': '2.82', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '2.40', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '2.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '1.93', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '2.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '1.40', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '2.29', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '1.28', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '2.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.02', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.', 'statisticalMethod': 'Generalized estimating equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'During the first 7 days of therapy', 'description': 'The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \\& fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. The maximum possible score was 14 and the minimum was 0.', 'unitOfMeasure': 'AOM-SOS score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score post-enrollment in the first 7 days of therapy. The score was based on AM and PM diaries completed at home by the child's parent."}, {'type': 'SECONDARY', 'title': 'The Distribution of Children Developing Worsening Symptoms Prior to Receiving 72 Hours of Study Medication According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Number of children with worsening symptoms', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Number of children unchanged or improved', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.24', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of children who develop worsening symptoms within the first 3 days of treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Before receiving 72 hours of study medication', 'description': "The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \\& fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1 and twice daily Days 2 and 3. Each set of ratings was summed to obtain an Acute Otitis Media-Severity of Symptoms (AOM-SOS) score. We compared a child's AOM-SOS scores in the first 72 hours to his/her score at enrollment to determine if a child's symptoms got worse (score increased) or remained unchanged or improved (score remained same or decreased).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children with follow-up whose parent(s) recorded AM and/or PM symptom scores in the first 3 days of treatment.'}, {'type': 'SECONDARY', 'title': 'The Mean Number of Times Analgesic Medication Was Administered to the Child According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '.37', 'spread': '.48', 'groupId': 'OG000'}, {'value': '.43', 'spread': '.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.35', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'A weighted regression model was used with weights equal to the number of days information regarding analgesic use was reported by the parents.', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the average number of doses of analgesic medication administered by parents.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'The first 10 days of follow-up', 'description': 'The parents were asked to complete a memory aid for the first 10 days of the study. One item asked them to record medications administered to the child in addition to the study medication. The data presented shows the mean number of times analgesic, i.e. ibuprofen or acetaminophen, was administered.', 'unitOfMeasure': 'times analgesic was administered', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The participants for analysis were the children with follow-up.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Mastoiditis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Perforation of tympanic membrane', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Protocol-defined diarrhea', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Diaper dermatitis', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Oral thrush', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with protocol-defined diarrhea.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '<.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with diaper dermatitis.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '.07', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with oral thrush.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '>.99', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with vomiting.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '>.99', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with rash.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '.99', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with mastoiditis.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '.08', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with perforation of their tympanic membrane.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this visit was 22.8.', 'description': 'Analysis was limited to those adverse events identified as being associated with either the study medication or the antimicrobials administered to children who were treatment failures or as being a complication of acute otitis media.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children randomized.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Presence of at least one AOM pathogen', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Absence of any AOM pathogen', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Presence of Streptococcus pneumoniae', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Absence of Streptococcus pneumoniae', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Presence of Haemophilus influenzae', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Absence of Haemophilus influenzae', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Presence of Moraxella catarrhalis', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Absence of Moraxella catarrhalis', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Presence of Streptococcus pyogenes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Absence of Streptococcus pyogenes', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '.85', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '.28', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End-of-therapy visit. The mean day for this visit was 11.6.', 'description': 'AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the end of therapy visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children with NP culture results at the end-of-therapy visit.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the End-of-therapy Visit According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Colonization with penicillin-susceptible S. pn', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'No colonization with penicillin-susceptible S. pn', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< .001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End-of-therapy visit. The mean day for this visit was 11.6.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children with NP culture results and results regarding penicillin susceptibility at the end-of-therapy visit.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Presence of at least one AOM pathogen', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Absence of any AOM pathogen', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Presence of Streptococcus pneumoniae', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Absence of Streptococcus pneumoniae', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Presence of Haemophilus influenzae', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Absence of Haemophilus influenzae', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Presence of Moraxella catarrhalis', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Absence of Moraxella catarrhalis', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Presence of Streptococcus pyogenes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Absence of Streptococcus pyogenes', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.10', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '.03', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '.96', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '.79', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}, {'pValue': '.98', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up visit. The mean day for this visit was 22.8.', 'description': 'AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the follow-up visit.', 'unitOfMeasure': 'participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children with NP culture results at the follow-up visit.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Colonization with penicillin-susceptible S. pn', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'No colonization with penicillin-susceptible S. pn', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up visit. The mean day for this visit was 22.8.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children with NP culture results and results regarding penicillin susceptibility at the follow-up visit.'}, {'type': 'SECONDARY', 'title': 'The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the On-therapy Visit According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Right ear', 'categories': [{'measurements': [{'value': '.36', 'spread': '.29', 'groupId': 'OG000'}, {'value': '.42', 'spread': '.29', 'groupId': 'OG001'}]}]}, {'title': 'Left ear', 'categories': [{'measurements': [{'value': '.39', 'spread': '.31', 'groupId': 'OG000'}, {'value': '.48', 'spread': '.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.03', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the on-therapy visit.', 'statisticalMethod': 'Generalized estimating equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'On-therapy visit. The mean day for this visit was 5.0.', 'description': 'For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.', 'unitOfMeasure': 'probability of effusion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the on-therapy visit.'}, {'type': 'SECONDARY', 'title': 'The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the End-of-therapy Visit According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Right ear', 'categories': [{'measurements': [{'value': '.32', 'spread': '.27', 'groupId': 'OG000'}, {'value': '.41', 'spread': '.28', 'groupId': 'OG001'}]}]}, {'title': 'Left ear', 'categories': [{'measurements': [{'value': '.33', 'spread': '.28', 'groupId': 'OG000'}, {'value': '.41', 'spread': '.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the end-of-therapy visit.', 'statisticalMethod': 'Generalized estimating equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'End-of-therapy visit. The mean day for this visit was 11.6.', 'description': 'For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.', 'unitOfMeasure': 'probability of effusion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the end-of-therapy visit.'}, {'type': 'SECONDARY', 'title': 'The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the Follow-up Visit According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Right ear', 'categories': [{'measurements': [{'value': '.28', 'spread': '.28', 'groupId': 'OG000'}, {'value': '.32', 'spread': '.29', 'groupId': 'OG001'}]}]}, {'title': 'Left ear', 'categories': [{'measurements': [{'value': '.27', 'spread': '.30', 'groupId': 'OG000'}, {'value': '.37', 'spread': '.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.', 'statisticalMethod': 'Generalized estimating equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up visit. The mean day for this visit was 22.8.', 'description': 'For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.', 'unitOfMeasure': 'probability of effusion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.'}, {'type': 'SECONDARY', 'title': 'The Mean Number of Visits to a Primary Care Provider (PCP) According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '.15', 'spread': '.40', 'groupId': 'OG000'}, {'value': '.23', 'spread': '.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.20', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding visits to primary care provider.', 'statisticalMethod': 'Generalized estimating equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.', 'description': 'At each visit parents were asked if they had taken their child to his/her primary care physician since the last contact. Medical records were also reviewed.', 'unitOfMeasure': 'visits to PCP', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.'}, {'type': 'SECONDARY', 'title': 'The Mean Number of Emergency Room Visits According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '.07', 'spread': '.26', 'groupId': 'OG000'}, {'value': '.07', 'spread': '.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.90', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding visits to emergency room', 'statisticalMethod': 'Generalized estimating equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.', 'description': 'At each visit we asked parents if they had to take their child to the emergency department. We also reviewed medical records to assure even more accurate reporting.', 'unitOfMeasure': 'visits to ER', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.'}, {'type': 'PRIMARY', 'title': 'The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Resolved by Day 1 - PM', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 1 - PM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 2 - AM', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 2 - AM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 2 - PM', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 2 - PM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 3 - AM', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 3 - AM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 3 - PM', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 3 - PM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 4', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 5', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 6', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 6', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 7', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 7', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.14', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.22', 'estimateComment': 'The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score \\<=1.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'The first 7 days on therapy', 'description': "Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches 0 or 1. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \\& fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible score was 14 and the minimum was 0. A score \\>=3 was required to be enrolled in the study.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants is equal to the number of children randomized.'}, {'type': 'PRIMARY', 'title': 'The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'title': 'Resolved by Day 1 - PM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 1 - PM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 2 - AM', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 2 - AM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 2 - PM', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 2 - PM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 3 - AM', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 3 - AM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 3 - PM', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 3 - PM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 4', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 5', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 6', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 6', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Resolved by Day 7', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Censored by Day 7', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '1.37', 'estimateComment': 'The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score \\<=1 on two consecutive occasions.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'The first 7 days on therapy', 'description': "Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches \\<= 1 on two consecutive occasions. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \\& fever) as 0, 1 or 2 (none, a little, a lot) \\& recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 \\& 3, \\& once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible was 14 and the minimum 0. A score \\>=3 was required to be enrolled in the study.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Mean Number of Antibiotic Prescriptions, Exclusive of Study Medication, According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '.35', 'spread': '.58', 'groupId': 'OG000'}, {'value': '.75', 'spread': '.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the number of antibiotic prescriptions, exclusive of the blinded study medication.', 'statisticalMethod': 'Generalized estimating equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.', 'description': 'This is the number of times, in the course of the study, a child required treatment with an antibiotic other than the blinded study medication.', 'unitOfMeasure': 'antibiotic prescriptions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The participants for analysis were the children with follow-up.'}, {'type': 'SECONDARY', 'title': 'The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Having Missed Work According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.93', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported missing work, i.e. number of such visits / total number of follow-up assessment visits.', 'statisticalMethod': 'Generalized estimating equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.', 'description': "At each visit, parent or parents were asked if their child's illness had caused either parent to miss a day or partial day of work. The total number of visits is summed across all participants in the respective treatment arms.", 'unitOfMeasure': 'visits', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.'}, {'type': 'SECONDARY', 'title': 'The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Making Special Daycare Arrangements According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.66', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported making special daycare arrangements, i.e. number of such visits / total number of follow-up assessment visits.', 'statisticalMethod': 'Generalized estimating equations', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.', 'description': "At each visit, parent or parents were asked if their child's illness had caused them to make alternative daycare arrangements. The total number of visits is summed across all participants in the respective treatment arms.", 'unitOfMeasure': 'visits', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.'}, {'type': 'SECONDARY', 'title': 'The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the On-therapy Visit According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.19', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '1.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.71', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the on-therapy visit.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'On-therapy visit. The mean day for this visit was 5.0.', 'description': 'Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.', 'unitOfMeasure': 'parental satisfaction score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the on-therapy visit.'}, {'type': 'SECONDARY', 'title': 'The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the End-of-therapy Visit According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.40', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '4.12', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the end-of-therapy visit.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'End-of-therapy visit. The mean day for this visit was 11.6.', 'description': 'Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.', 'unitOfMeasure': 'parental satisfaction score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the end-of-therapy visit.'}, {'type': 'SECONDARY', 'title': 'The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the Follow-up Visit According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.53', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '4.17', 'spread': '1.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.005', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the follow-visit visit.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Follow-up visit. The mean day for this visit was 22.8.', 'description': 'Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.', 'unitOfMeasure': 'parental satisfaction score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the follow-up visit.'}, {'type': 'PRIMARY', 'title': 'The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '3.42', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: There is no difference between the two treatment groups regarding the mean weighted average acute otitis media - severity of symptom (AOM-SOS) score (symptom burden), post-enrollment, over the first 7 days of therapy.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'During the first 7 days of therapy', 'description': 'The AOM-SOS score is derived from parent scoring each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \\& fever) associated with AOM as 0, 1 or 2 (none, a little, a lot). The AOM-SOS was administered twice daily the first 3 days of follow-up, then daily for 4 additional days. Symptom burden for each child is determined by calculating the weighted average of symptom scores post-enrollment over the first 7 days of therapy. Scores are weighted by 1/k, where k is the number of post-enrollment assessments taken on that day.', 'unitOfMeasure': 'AOM-SOS score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score post-enrollment in the first 7 days of therapy. The score was based on diaries completed at home by the child's parent."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'A child is considered a completer if he/she had at least one visit after the end of therapy.', 'groupId': 'FG000', 'numSubjects': '142'}, {'comment': 'A child is considered a completer if he/she had at least one visit after the end of therapy.', 'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Children were recruited over 3 respiratory seasons, beginning on 11/31/2006 with the last enrollment on 3/31/2009. There were 2 enrollment sites, as well as referrals from private pediatricians. One site was a large private practice; the other was a large hospital based practice. This was for generalizability.', 'preAssignmentDetails': 'There were 2 children who signed consents but were not randomized. One parent withdrew consent and one child, referred from an outside practice, was found to not be eligible.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Amoxicillin-Clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '6-11 months', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}, {'title': '12-17 months', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': '18-23 months', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Colonization With AOM Pathogens', 'classes': [{'title': 'Presence of at least one AOM pathogen', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}]}, {'title': 'Absence of any AOM pathogen', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'No culture result', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'AOM pathogens refer to Streptococcus Pneumoniae, Haemophilus Influenzae, Moraxella Catarrhalis or Streptococcus Pyogenes', 'unitOfMeasure': 'participants'}, {'title': 'Degree of tympanic membrane bulging', 'classes': [{'title': 'Slight', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}, {'title': 'Marked', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The degree of bulging for the ear with the greater level of bulging at entry is summarized. The otoscopists rated this as slight bulging, moderate bulging or marked bulging. The otoscopists have all been validated for inter-observer reliability.', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Parents were asked if their child is Hispanic.', 'unitOfMeasure': 'participants'}, {'title': 'Exposed to other children', 'classes': [{'title': 'Exposed', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}, {'title': 'Not exposed', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Exposed to other children is defined as a child being exposed to 3 or more children, including siblings, for at least 10 hours per week.\n\nNot exposed is defined as any child who does not meet this criteria.', 'unitOfMeasure': 'participants'}, {'title': 'Health insurance status', 'classes': [{'title': 'Private', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': 'Medicaid', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "Parents were asked the child's health insurance status", 'unitOfMeasure': 'participants'}, {'title': 'History of recurrent acute otitis media', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Records were obtained and reviewed for a history of recurrent acute otitis media.\n\n"Yes" indicates that the child had a documented history of at least 3 acute otitis media episodes in the past 6 months or at least 4 episodes in the past year.\n\n"No" indicates that the child did not meet the criteria for "Yes".', 'unitOfMeasure': 'participants'}, {'title': 'Laterality of Acute Otitis Media', 'classes': [{'title': 'Bilateral', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}, {'title': 'Unilateral', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Bilateral means that both ears were found to be acute. Unilateral means that only one ear was found to be acute, the other ear could have had middle ear effusion or have been free of middle ear effusion.', 'unitOfMeasure': 'participants'}, {'title': 'Maternal Education', 'classes': [{'title': 'Less than high school', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'High school graduate', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}]}, {'title': 'College graduate', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Parents were asked about the highest level of maternal education.', 'unitOfMeasure': 'participants'}, {'title': 'Race', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}, {'title': 'African-American', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Parents were asked what race or races they would use to describe their child. Caucasian and African-American are listed when only one race was given. Other includes other races as well as any who gave more than one race.', 'unitOfMeasure': 'participants'}, {'title': 'Severity of symptoms score', 'classes': [{'title': 'Score of 3-5', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'Score of 6-8', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': 'Score of 9-11', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': 'Score of 12-14', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "Parents completed the Acute Otitis-Media-Severity of Symptoms (AOM-SOS)scale prior to their child's ear exam. It's a list of 7 symptoms associated with Acute Otitis-media.\n\n\\[tugging/rubbing/holding ears; crying more; irritable/fussy; difficulty sleeping; less playful/active; eating less; fever or warm to touch. The parent rates these symptoms as No (0 points), A little (1 point) or A lot (2 points). Children must have at least 3 points to qualify, so the minimum score is 3, the maximum is 14.", 'unitOfMeasure': 'participants'}, {'title': 'Study Site', 'classes': [{'title': "Children's Hospital of Pittsburgh (Pittsburgh, PA)", 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}, {'title': 'Armstrong Pediatrics (Kittanning, PA)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "Children's Hospital of Pittsburgh (CHP) is the Primary Care Center of CHP. Armstrong Pediatrics is a large community practice in Kittanning, PA.", 'unitOfMeasure': 'participants'}, {'title': 'Mean Estimated Probability of Middle Ear Effusion', 'classes': [{'title': 'Right ear', 'categories': [{'measurements': [{'value': '.42', 'spread': '.31', 'groupId': 'BG000'}, {'value': '.39', 'spread': '.27', 'groupId': 'BG001'}, {'value': '.41', 'spread': '.29', 'groupId': 'BG002'}]}]}, {'title': 'Left ear', 'categories': [{'measurements': [{'value': '.35', 'spread': '.30', 'groupId': 'BG000'}, {'value': '.44', 'spread': '.29', 'groupId': 'BG001'}, {'value': '.40', 'spread': '.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.', 'unitOfMeasure': 'probability of effusion', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean score of AOM-SOS', 'classes': [{'categories': [{'measurements': [{'value': '7.69', 'spread': '2.85', 'groupId': 'BG000'}, {'value': '7.90', 'spread': '2.87', 'groupId': 'BG001'}, {'value': '7.80', 'spread': '2.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "This is the mean score for each arm. Parents completed the Acute Otitis Media -Severity of Symptoms (AOM-SOS) scale prior to their child's ear exam. It's a list of 7 symptoms associated with Acute Otitis-media.\n\n\\[tugging/rubbing/holding ears; crying more; irritable/fussy; difficulty sleeping; less playful/active; eating less; fever or warm to touch. The parent rates these symptoms as No (0 points), A little (1 point) or A lot (2 points). Children must have at least 3 points to qualify, so the minimum score is 3, the maximum is 14.", 'unitOfMeasure': 'AOM-SOS score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2006-09-14', 'resultsFirstSubmitDate': '2010-04-13', 'studyFirstSubmitQcDate': '2006-09-14', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-07-15', 'studyFirstPostDateStruct': {'date': '2006-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment', 'timeFrame': 'The first 7 days on therapy', 'description': "Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches 0 or 1. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \\& fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible score was 14 and the minimum was 0. A score \\>=3 was required to be enrolled in the study."}, {'measure': 'The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment', 'timeFrame': 'The first 7 days on therapy', 'description': "Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches \\<= 1 on two consecutive occasions. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \\& fever) as 0, 1 or 2 (none, a little, a lot) \\& recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 \\& 3, \\& once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible was 14 and the minimum 0. A score \\>=3 was required to be enrolled in the study."}, {'measure': 'The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment', 'timeFrame': 'During the first 7 days of therapy', 'description': 'The AOM-SOS score is derived from parent scoring each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \\& fever) associated with AOM as 0, 1 or 2 (none, a little, a lot). The AOM-SOS was administered twice daily the first 3 days of follow-up, then daily for 4 additional days. Symptom burden for each child is determined by calculating the weighted average of symptom scores post-enrollment over the first 7 days of therapy. Scores are weighted by 1/k, where k is the number of post-enrollment assessments taken on that day.'}], 'secondaryOutcomes': [{'measure': 'The Distribution of Clinical Failures by the On-therapy Visit According to Treatment Assignment', 'timeFrame': 'On-therapy visit. The mean day for this visit was 5.0.', 'description': 'Clinical failure by the on-therapy visit is defined as either failure to achieve substantial improvement in symptoms, or worsening of otoscopic signs, or both.'}, {'measure': 'The Distribution of Clinical Failures by the End-of-therapy Visit According to Treatment Assignment', 'timeFrame': 'End-of-therapy visit. The mean day for this visit was 11.6.', 'description': 'Clinical failure by the end of therapy visit is defined as failure to achieve complete or virtually complete resolution of symptoms and of otoscopic signs, but without regard to the persistence of middle ear effusion.'}, {'measure': 'The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment', 'timeFrame': 'During the first 7 days of therapy', 'description': 'The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \\& fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. The maximum possible score was 14 and the minimum was 0.'}, {'measure': 'The Distribution of Children Developing Worsening Symptoms Prior to Receiving 72 Hours of Study Medication According to Treatment Assignment', 'timeFrame': 'Before receiving 72 hours of study medication', 'description': "The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite \\& fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1 and twice daily Days 2 and 3. Each set of ratings was summed to obtain an Acute Otitis Media-Severity of Symptoms (AOM-SOS) score. We compared a child's AOM-SOS scores in the first 72 hours to his/her score at enrollment to determine if a child's symptoms got worse (score increased) or remained unchanged or improved (score remained same or decreased)."}, {'measure': 'The Mean Number of Times Analgesic Medication Was Administered to the Child According to Treatment Assignment', 'timeFrame': 'The first 10 days of follow-up', 'description': 'The parents were asked to complete a memory aid for the first 10 days of the study. One item asked them to record medications administered to the child in addition to the study medication. The data presented shows the mean number of times analgesic, i.e. ibuprofen or acetaminophen, was administered.'}, {'measure': 'The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment', 'timeFrame': 'We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this visit was 22.8.', 'description': 'Analysis was limited to those adverse events identified as being associated with either the study medication or the antimicrobials administered to children who were treatment failures or as being a complication of acute otitis media.'}, {'measure': 'The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment', 'timeFrame': 'End-of-therapy visit. The mean day for this visit was 11.6.', 'description': 'AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the end of therapy visit.'}, {'measure': 'The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the End-of-therapy Visit According to Treatment Assignment', 'timeFrame': 'End-of-therapy visit. The mean day for this visit was 11.6.'}, {'measure': 'The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment', 'timeFrame': 'Follow-up visit. The mean day for this visit was 22.8.', 'description': 'AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the follow-up visit.'}, {'measure': 'The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the Follow-up Visit', 'timeFrame': 'Follow-up visit. The mean day for this visit was 22.8.'}, {'measure': 'The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the On-therapy Visit According to Treatment Assignment', 'timeFrame': 'On-therapy visit. The mean day for this visit was 5.0.', 'description': 'For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.'}, {'measure': 'The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the End-of-therapy Visit According to Treatment Assignment', 'timeFrame': 'End-of-therapy visit. The mean day for this visit was 11.6.', 'description': 'For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.'}, {'measure': 'The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the Follow-up Visit According to Treatment Assignment', 'timeFrame': 'Follow-up visit. The mean day for this visit was 22.8.', 'description': 'For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.'}, {'measure': 'The Mean Number of Visits to a Primary Care Provider (PCP) According to Treatment Assignment', 'timeFrame': 'This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.', 'description': 'At each visit parents were asked if they had taken their child to his/her primary care physician since the last contact. Medical records were also reviewed.'}, {'measure': 'The Mean Number of Emergency Room Visits According to Treatment Assignment', 'timeFrame': 'This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.', 'description': 'At each visit we asked parents if they had to take their child to the emergency department. We also reviewed medical records to assure even more accurate reporting.'}, {'measure': 'The Mean Number of Antibiotic Prescriptions, Exclusive of Study Medication, According to Treatment Assignment', 'timeFrame': 'This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.', 'description': 'This is the number of times, in the course of the study, a child required treatment with an antibiotic other than the blinded study medication.'}, {'measure': 'The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Having Missed Work According to Treatment Assignment', 'timeFrame': 'This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.', 'description': "At each visit, parent or parents were asked if their child's illness had caused either parent to miss a day or partial day of work. The total number of visits is summed across all participants in the respective treatment arms."}, {'measure': 'The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Making Special Daycare Arrangements According to Treatment Assignment', 'timeFrame': 'This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.', 'description': "At each visit, parent or parents were asked if their child's illness had caused them to make alternative daycare arrangements. The total number of visits is summed across all participants in the respective treatment arms."}, {'measure': 'The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the On-therapy Visit According to Treatment Assignment', 'timeFrame': 'On-therapy visit. The mean day for this visit was 5.0.', 'description': 'Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.'}, {'measure': 'The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the End-of-therapy Visit According to Treatment Assignment', 'timeFrame': 'End-of-therapy visit. The mean day for this visit was 11.6.', 'description': 'Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.'}, {'measure': 'The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the Follow-up Visit According to Treatment Assignment', 'timeFrame': 'Follow-up visit. The mean day for this visit was 22.8.', 'description': 'Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute otitis media, infants, children'], 'conditions': ['Acute Otitis Media']}, 'referencesModule': {'references': [{'pmid': '37171965', 'type': 'DERIVED', 'citation': 'Shaikh N, Hoberman A, Paradise JL, Rockette HE, Kurs-Lasky M, Martin JM. Association Between Nasopharyngeal Colonization and Clinical Outcome in Children With Acute Otitis Media. Pediatr Infect Dis J. 2023 Aug 1;42(8):e274-e277. doi: 10.1097/INF.0000000000003956. Epub 2023 Apr 26.'}, {'pmid': '21226576', 'type': 'DERIVED', 'citation': 'Hoberman A, Paradise JL, Rockette HE, Shaikh N, Wald ER, Kearney DH, Colborn DK, Kurs-Lasky M, Bhatnagar S, Haralam MA, Zoffel LM, Jenkins C, Pope MA, Balentine TL, Barbadora KA. Treatment of acute otitis media in children under 2 years of age. N Engl J Med. 2011 Jan 13;364(2):105-15. doi: 10.1056/NEJMoa0912254.'}, {'pmid': '21098526', 'type': 'DERIVED', 'citation': 'Hoberman A, Paradise JL, Shaikh N, Greenberg DP, Kearney DH, Colborn DK, Rockette HE, Kurs-Lasky M, McEllistrem MC, Zoffel LM, Balentine TL, Barbadora KA, Wald ER. Pneumococcal resistance and serotype 19A in Pittsburgh-area children with acute otitis media before and after introduction of 7-valent pneumococcal polysaccharide vaccine. Clin Pediatr (Phila). 2011 Feb;50(2):114-20. doi: 10.1177/0009922810384259. Epub 2010 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics. The study will compare two treatment strategies, "watchful waiting" or treatment with antibiotics, to determine which is more appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23 months, with AOM will be enrolled in the study. They will be treated either with Augmentin (an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will be asked to write information about their child in a Patient Diary. A general physical exam, including an ear exam, will be performed 4 times during the study. A mucus sample will be collected from the back of each child\'s nose. Parents will be asked questions during phone calls and at every visit. If a child has not improved or has worsened, the investigators will prescribe a different antibiotic that is known to kill resistant germs.', 'detailedDescription': "The purpose of this randomized, double-masked, placebo-controlled, single-center clinical trial is to determine the efficacy of antimicrobials in young children with acute otitis media (AOM). The primary objectives are to compare time to resolution of symptoms (initial and sustained) in children receiving amoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses for 10 days) to children receiving placebo (in 2 divided doses for 10 days), and to compare the weighted average AOM-Severity of Symptoms (AOM-SOS) scores in the two groups during days 1-7. The secondary objectives are to: evaluate the clinical efficacy of amoxicillin-clavulanate vs. placebo at the on-therapy visit (Day 4-5, and at least 72 hours after initial dose of study medication); evaluate the clinical efficacy of amoxicillin-clavulanate vs. placebo at the end-of-therapy visit (Day 10-12); compare AOM-SOS and AOM-Faces scales between treatment groups during each of the first 7 days of therapy and at all study visits; compare the proportion of children in each treatment group who develop worsening symptoms before having received 72 hours of study medication; compare the two treatment groups regarding the quantity of analgesic medication administered by children's parents; compare the incidence of adverse events accompanying the two treatment regimens; compare the effects of amoxicillin-clavulanate vs. placebo on the overall proportion of children with nasopharyngeal (NP) colonization with AOM pathogens (S. pneumoniae, H. influenzae, M. catarrhalis, S. pyogenes), and on the proportion of children with NP colonization with penicillin non-susceptible S. pneumoniae; compare the 2 treatment groups regarding tympanometric outcomes at the on-therapy (Day 4-5), end-of-therapy (Day 10-12) and follow-up (Day 21-25) visits, using an algorithm that permits estimation of the probability of middle ear effusion given any particular tympanographic configuration; compare direct and indirect medical costs between the two treatment groups; and compare parental satisfaction with therapy between the two treatment groups. Participants will include 268 children, aged 6 to 23 months, diagnosed with acute otitis media in Western Pennsylvania. These participants will be recruited into the study at Children's Hospital of Pittsburgh (CHP), Pittsburgh, PA, and Armstrong Pediatrics (Children's Community Pediatrics: an affiliate of CHP) in Kittanning, PA. Subjects will be randomized to receive either amoxicillin-clavulanate or placebo twice daily for 10 days. Parents of the subject will be asked to track symptom status, medication use (study medication and acetaminophen), fever and diarrhea in a study memory aid. Study procedures will include a medical history, vital signs, weight, clinical information regarding signs and symptoms of infection, nasopharyngeal specimens, and a physical exam including tympanometry. Each child will be examined three additional times: 4-5 days after starting the medicine, study day 10-12 and 21-25 days after enrolling in the study. During these visits, study staff will review the child's symptoms and examine the child's ears. The study staff will also obtain a nasopharyngeal culture in order to look for resistant bacteria and to make appropriate changes in antibiotic treatment. Daily telephone assessments will be made by study staff on days 2, 3, and 4 of therapy to make sure the child is getting better. The study staff will see a child anytime a parent feels their child has not improved or has worsened."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* aged 6 to 23 months\n* have received at least two doses of pneumococcal conjugate vaccine (Prevnar) and Haemophilus influenzae type B vaccine\n* have evidence of acute otitis media (AOM) defined as:\n\n 1. Recent (within 48 hours), onset of signs and symptoms and a score of greater than or equal to 3 on the AOM-SOS scale.\n 2. Middle ear effusion evidenced by at least two of the following:\n* decreased or absent tympanic membrane mobility by pneumatic otoscopy,\n* yellow or white discoloration of the tympanic membrane,\n* opacification of the tympanic membrane, plus\n* 1+ bulging of the tympanic membrane with either marked erythema or otalgia, or\n* 2+ or 3+ bulging of the tympanic membrane\n\nExclusion Criteria:\n\n* certain signs or symptoms (e.g., toxic appearance \\[capillary refill greater than 3 seconds, systolic blood pressure less than 60 mm Hg\\], otalgia for a period greater than 48 hours, spontaneous perforation of the tympanic membrane and drainage or temperature greater than or equal to 105 degrees F);\n* clinical or anatomical characteristics that might obscure response to treatment (e.g., tympanostomy tube\\[s\\] in place or a history of tympanostomy tubes, unrepaired or repaired overt or submucous cleft palate, high-arched palate, or Down's syndrome);\n* underlying systemic problems that might obscure response to infection (e.g., serious underlying disease \\[e.g., cystic fibrosis, neoplasm, juvenile diabetes\\]), concomitant infection that would preclude evaluation of the response of the child's AOM to study medication, known renal insufficiency (i.e., serum creatinine greater than or equal to 1.5 times upper limit of normal for age), known hepatic insufficiency or a history of amoxicillin-clavulanate-associated cholestatic jaundice or hepatic dysfunction, history of immune dysfunction, deficiency or receipt of immunosuppressive therapy, chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease), malignancy;\n* sensorineural hearing loss either unilateral or bilateral;\n* comedications (e.g., systemic corticosteroids at any point while enrolled in the study, more than one dose of systemic antimicrobial therapy within 96, any investigational drug or vaccine;\n* hypersensitivity to penicillin, amoxicillin or amoxicillin-clavulanate, or phenylketonuria or known hypersensitivity to aspartame;\n* unable to complete the study protocol or not having access to a telephone; and\n* current enrollment in another study or previously enrolled in this study."}, 'identificationModule': {'nctId': 'NCT00377260', 'briefTitle': 'Acute Otitis Media (AOM) Therapy Trial in Young Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Efficacy of Antimicrobials in Young Children With Acute Otitis Media (AOM)', 'orgStudyIdInfo': {'id': '05-0142'}, 'secondaryIdInfos': [{'id': 'U01AI066007', 'link': 'https://reporter.nih.gov/quickSearch/U01AI066007', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amoxicillin-clavulanate', 'description': 'Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.', 'interventionNames': ['Drug: amoxicillin-clavulanate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Reconstituted placebo in 2 divided doses for 10 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'amoxicillin-clavulanate', 'type': 'DRUG', 'otherNames': ['Augmentin', 'amox-clav'], 'description': 'Augmentin ES-600™: Amoxicillin-clavulanate potassium (600/42.9 mg per 5 mL), administered at a dose of 90/6.4 mg/kg/day in 2 divided doses for 10 days with strawberry cream flavor.', 'armGroupLabels': ['Amoxicillin-clavulanate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Same base formulation of the licensed product Augmentin ES-600™, with the same strawberry cream flavor.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Alejandro Hoberman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of General Academic Pediatrics', 'investigatorFullName': 'Alejandro Hoberman', 'investigatorAffiliation': 'University of Pittsburgh'}}}}