Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-02-08 @ 2:48 AM
Study NCT ID:
NCT02223520
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2014-08-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016712', 'term': 'Mupirocin'}, {'id': 'D002710', 'term': 'Chlorhexidine'}, {'id': 'C010882', 'term': 'chlorhexidine gluconate'}], 'ancestors': [{'id': 'D004852', 'term': 'Epoxy Compounds'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amilsto1@jhmi.edu', 'phone': '410-614-3917', 'title': 'Aaron M. Milstone, M.D., M.H.S.', 'organization': 'Johns Hopkins Medical Institutions'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During the 5 days of treatment', 'description': 'Adverse events were assessed in mothers not neonates.', 'eventGroups': [{'id': 'EG000', 'title': 'Mupirocin and Chlorhexidine', 'description': 'Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.\n\nMupirocin and Chlorhexidine', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 9, 'seriousNumAtRisk': 147, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Ointment and Placebo Cloths', 'description': 'Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.\n\nPlacebo ointment and placebo cloths', 'otherNumAtRisk': 160, 'deathsNumAtRisk': 160, 'otherNumAffected': 16, 'seriousNumAtRisk': 160, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nose irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retained placenta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mupirocin and Chlorhexidine', 'description': 'Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.\n\nMupirocin and Chlorhexidine'}, {'id': 'OG001', 'title': 'Placebo Ointment and Placebo Cloths', 'description': 'Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.\n\nPlacebo ointment and placebo cloths'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 90 days', 'description': 'Primary outcome is neonatal acquisition of S. aureus strain that is concordant to parental S. aureus strain as determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Survival analysis techniques will be used to compare the hazard of concordant colonization comparing Treatment and Control Groups.', 'unitOfMeasure': 'neonatal S. aureus infections', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is being assessed in the neonate population not the mothers. 12 of the neonates in the intervention group and 6 in the placebo group were lost to follow-up and could not be included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mupirocin and Chlorhexidine', 'description': 'Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.\n\nMupirocin and Chlorhexidine'}, {'id': 'FG001', 'title': 'Placebo Ointment and Placebo Cloths', 'description': 'Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.\n\nPlacebo ointment and placebo cloths'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '101 neonates of these parents were enrolled. 12 were lost to follow-up.', 'groupId': 'FG000', 'numSubjects': '147'}, {'comment': '107 neonates of these parents were enrolled. 6 were lost to follow-up.', 'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mupirocin and Chlorhexidine', 'description': 'Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.\n\nMupirocin and Chlorhexidine'}, {'id': 'BG001', 'title': 'Placebo Ointment and Placebo Cloths', 'description': 'Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.\n\nPlacebo ointment and placebo cloths'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '7.2', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '7.54', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age of neonate at time of enrollment (days)', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Johns Hopkins Hospital', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}, {'title': 'Johns Hopkins Bayview', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}, {'title': 'Parent age at the time of enrollment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.3', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '30.9', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '30.6', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This is a measure for the parents. Parent demographics collected by parent interview or parent completion of form. Parents sometimes skipped questions on survey form and were not always available to capture missing demographic data that was not in the medical record.'}, {'title': 'Parent antibiotic use in past 6 months', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}, {'title': 'Unreported/Unknown', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parent history of mupirocin use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}, {'title': 'Unreported/Unknown', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parent history of Staphylococcus aureus infection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}, {'title': 'Unreported/Unknown', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Level of education of parent', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}], 'categories': [{'title': 'At most high school', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Some or completed college', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'Graduate degree', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'No. of singletons', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Neonates that were delivered as singletons.', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}, {'title': 'Birthweight of neonate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1982.5', 'spread': '972.8', 'groupId': 'BG000'}, {'value': '1986.9', 'spread': '949.4', 'groupId': 'BG001'}, {'value': '1984.8', 'spread': '958.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}, {'title': 'Child delivery method', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Vaginal birth', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}, {'title': 'Cesarean section', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}, {'title': 'Neonate inborn or transferred in', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Inborn in JHH/JHBMC', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}, {'title': 'Transferred from another hospital to JHH/JHBMC', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Transferred from home to JHH/JHBMC', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Inborn was defined as neonates who were born at Johns Hopkins Hospital (JHH)/Johns Hopkins Bayview Medical Center (JHBMC) instead of being transferred to JHH/JHBMC from an outside hospital or home.', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}, {'title': 'Gestational age at birth', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32.9', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '33.1', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '33', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}, {'title': 'Maternal antibiotic use during delivery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Neonates whose mothers reported using antibiotic during delivery.', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}, {'title': 'Maternal Group B Streptococcus positive', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Positive', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Unreported/Unknown', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Neonates whose mothers reported testing positive for Group B Streptococcus.', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}, {'title': 'Maternal HIV Positive', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Positive', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'Unreported/Unknown', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Neonates whose mothers reported being positive for HIV.', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline measure reported is for the neonates not the parents.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-30', 'size': 1231337, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-26T12:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-07', 'studyFirstSubmitDate': '2014-08-21', 'resultsFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2014-08-21', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-02', 'studyFirstPostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain', 'timeFrame': 'Up to 90 days', 'description': 'Primary outcome is neonatal acquisition of S. aureus strain that is concordant to parental S. aureus strain as determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Survival analysis techniques will be used to compare the hazard of concordant colonization comparing Treatment and Control Groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Staphylococcus aureus', 'Infection', 'Colonization', 'Transmission', 'Neonate'], 'conditions': ['Staph Aureus Colonization', 'Staph Aureus Infection']}, 'referencesModule': {'references': [{'pmid': '31886828', 'type': 'DERIVED', 'citation': 'Milstone AM, Voskertchian A, Koontz DW, Khamash DF, Ross T, Aucott SW, Gilmore MM, Cosgrove SE, Carroll KC, Colantuoni E. Effect of Treating Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit: A Randomized Clinical Trial. JAMA. 2020 Jan 28;323(4):319-328. doi: 10.1001/jama.2019.20785.'}, {'pmid': '26353875', 'type': 'DERIVED', 'citation': 'Milstone AM, Koontz DW, Voskertchian A, Popoola VO, Harrelson K, Ross T, Aucott SW, Gilmore MM, Carroll KC, Colantuoni E. Treating Parents to Reduce NICU Transmission of Staphylococcus aureus (TREAT PARENTS) trial: protocol of a multisite randomised, double-blind, placebo-controlled trial. BMJ Open. 2015 Sep 9;5(9):e009274. doi: 10.1136/bmjopen-2015-009274.'}]}, 'descriptionModule': {'briefSummary': 'This trial will test the hypothesis that treating parents of neonates requiring NICU care with intranasal mupirocin and topical chlorhexidine bathing will reduce the spread of S. aureus from parents to neonates.', 'detailedDescription': 'The TREAT PARENTS Trial, or Treating Parents to Reduce NICU Transmission of S. aureus, is a placebo-controlled, double-masked, randomized clinical trial to test the hypothesis that treatment of S. aureus colonized parents with intranasal mupirocin and topical chlorhexidine gluconate antisepsis will decrease neonatal S. aureus acquisition. All neonates admitted to the Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center NICUs will be pre-screened and parents will be approached for enrollment in the study. After consent and baseline screening, 400 neonate-parent pairs will be randomized; only neonates who have a parent colonized with S. aureus will be randomized. Parents will receive a 5 day treatment with intranasal mupirocin plus topical chlorhexidine gluconate antisepsis or placebo.\n\nAfter recruitment and informed consent, parents will undergo pre-randomization screening. If both parents screen negative for S. aureus colonization, the neonate will be ineligible for the randomization and parents will be informed that the parents are not colonized at that time with S. aureus. If either parent screens positive for S. aureus, then both parents as a pair will be eligible for randomization to one of the two possible masked treatment arms. The neonate-parent "pair" will be the unit of randomization and each parent will be allocated to the same group if both consent.\n\nAfter the baseline neonate testing for S. aureus colonization, repeat testing will be performed every 7 days for the neonates until the neonate acquires S. aureus colonization or is discharged from the NICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonate has never had a clinical or surveillance culture grow S. aureus\n* Neonate was transferred from another hospital or admitted from home and had admission screening cultures for S. aureus colonization that were negative (if admission cultures were not performed, the cultures will be performed as part of the pre-randomization screening process)\n* Parent(s) is(are) able to visit the child at the bedside\n* Parent(s) test positive for S. aureus at screening\n* Neonate has anticipated stay longer than 5 days in the NICU (if estimated stay is unclear, parents can be screened for S. aureus colonization and decision to randomize can be delayed until hospital day 3 or 4 after reassessment of anticipated stay).\n* Parents is(are) willing to be randomized\n* No documented or reported allergies to any agent used in either treatment regimen\n* Able to perform written informed consent\n\nExclusion Criteria:\n\n* Allergies to any agent used in either treatment regimen\n* Neonate has had a prior clinical or surveillance culture grow S. aureus\n* Neonate admitted to NICU from home and is greater than 7 days of age\n* Neonate admitted to NICU from another hospital and is greater than 7 days of age\n* Neonate is a ward of the State\n* Not able to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT02223520', 'acronym': 'TREAT PARENTS', 'briefTitle': 'Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Treating Parents to Reduce Neonatal Intensive Care Unit (NICU) Transmission of Staphylococcus Aureus', 'orgStudyIdInfo': {'id': 'NA_00092982'}, 'secondaryIdInfos': [{'id': 'R01HS022872', 'link': 'https://reporter.nih.gov/quickSearch/R01HS022872', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mupirocin and Chlorhexidine', 'description': 'Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.', 'interventionNames': ['Drug: Mupirocin and Chlorhexidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo ointment and placebo cloths', 'description': 'Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.', 'interventionNames': ['Drug: Placebo ointment and placebo cloths']}], 'interventions': [{'name': 'Mupirocin and Chlorhexidine', 'type': 'DRUG', 'otherNames': ['bactroban', 'chlorhexidine gluconate'], 'armGroupLabels': ['Mupirocin and Chlorhexidine']}, {'name': 'Placebo ointment and placebo cloths', 'type': 'DRUG', 'armGroupLabels': ['Placebo ointment and placebo cloths']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Aaron Milstone, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}