Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-02-03 @ 4:35 AM
Study NCT ID:
NCT00643292
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2008-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections
Sponsor:
Organization:
Raw JSON
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'Heterocyclic Compounds'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 902}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-16', 'studyFirstSubmitDate': '2008-03-19', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical response (cure or failure) in the Clinical Per Protocol population', 'timeFrame': 'Test of Cure (TOC) visit (Day 12-14)'}], 'secondaryOutcomes': [{'measure': 'summary of baseline susceptibilities', 'timeFrame': 'Study endpoint'}, {'measure': 'clinical response (cure or failure) in the Clinical Per Protocol population', 'timeFrame': 'On-Treatment (OT) visit (Day 4-6)'}, {'measure': 'Laboratory abnormalities', 'timeFrame': 'Baseline and TOC visit'}, {'measure': 'bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population', 'timeFrame': 'TOC visit'}, {'measure': 'adverse events', 'timeFrame': 'Continuous'}, {'measure': 'clinical response (cure or failure) in all populations except the Clinical Per Protocol population', 'timeFrame': 'OT visit and TOC visit'}, {'measure': 'clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population', 'timeFrame': 'OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32)'}, {'measure': 'clinical response (cure or failure) in the Clinical Per Protocol population', 'timeFrame': 'LTFU visit'}, {'measure': 'clinical scores for the Clinical Per Protocol population', 'timeFrame': 'OT visit and TOC visit'}, {'measure': 'persistence of middle ear fluid for the Clinical Per Protocol population', 'timeFrame': 'TOC visit and LTFU visit'}, {'measure': 'audiologic response', 'timeFrame': 'LTFU visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Otitis Media']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661073&StudyName=A%20Single%2C%20High-Dose%20Azithromycin%20Extended%20Release%20%2860%20mg/kg%29%20Compared%20with%2010%20Days%20of%20High-Dose%20Amoxicillin%20Clavulanate%20in%20Children%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent or recurrent ear infections'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOutpatients with clinical evidence of acute otitis media who weigh at least 5 kg were included\n\nExclusion Criteria:\n\nPatients with previously diagnosed disease of immune function, treatment with any systemic antibiotic within the previous 7 days, or cleft lip/palate or other anatomic abnormality predisposing to otitis media were excluded.'}, 'identificationModule': {'nctId': 'NCT00643292', 'briefTitle': 'A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Amoxicillin/Clavulanate Potassium (Augmentin ES-600 Trademark) for the Treatment of Acute Otitis Media in Children Undergoing Diagnostic Tympanocentesis', 'orgStudyIdInfo': {'id': 'A0661073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: 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