# 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

> **NCT00643292** · PHASE3 · COMPLETED · sponsor: **Pfizer** · enrollment: 902 (actual)

## Conditions studied

- Acute Otitis Media

## Interventions

- **DRUG:** amoxicillin/clavulanate postassium (Augmentin ES-600)
- **DRUG:** azithromycin SR

## Key facts

- **NCT ID:** NCT00643292
- **Lead sponsor:** Pfizer
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2003-01
- **Primary completion:** —
- **Final completion:** 2004-05
- **Target enrollment:** 902 (ACTUAL)
- **Last updated:** 2011-05-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00643292

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT00643292. Licensed CC0.

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