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
Phase 3
Completed
- Conditions
- Acute Otitis Media
- Interventions
- Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)Drug: azithromycin SR
- Registration Number
- NCT00643292
- Lead Sponsor
- Pfizer
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 902
Inclusion Criteria
Outpatients with clinical evidence of acute otitis media who weigh at least 5 kg were included
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Exclusion Criteria
Patients 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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 amoxicillin/clavulanate postassium (Augmentin ES-600) - 2 azithromycin SR -
- Primary Outcome Measures
Name Time Method clinical response (cure or failure) in the Clinical Per Protocol population Test of Cure (TOC) visit (Day 12-14)
- Secondary Outcome Measures
Name Time Method adverse events Continuous summary of baseline susceptibilities Study endpoint clinical response (cure or failure) in the Clinical Per Protocol population LTFU visit Laboratory abnormalities Baseline and TOC visit bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population TOC visit clinical response (cure or failure) in all populations except the Clinical Per Protocol population OT visit and TOC visit clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32) clinical scores for the Clinical Per Protocol population OT visit and TOC visit persistence of middle ear fluid for the Clinical Per Protocol population TOC visit and LTFU visit audiologic response LTFU visit
Trial Locations
- Locations (1)
Pfizer Investigational Site