NCT00643292

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 902 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 3 Months – 48 Months
• Healthy volunteers: Not accepted

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

Conditions

• Acute Otitis Media

Interventions

Type	Name	Description
DRUG	amoxicillin/clavulanate postassium (Augmentin ES-600)	amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
DRUG	azithromycin SR	azithromycin SR 60 mg/kg x 1 dose

Timeline

• Start date: 2003-01-01
• Completion: 2004-05-01
• First posted: 2008-03-26
• Last updated: 2011-05-17

Locations

48 sites across 13 countries: United States, Argentina, Chile, Costa Rica, Dominican Republic, Estonia, Guatemala, Israel, Mexico, Panama, Poland, Russia, Slovakia