drugset / Trial / 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
RandomizedParallel-groupDouble-blindTreatment
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
Timeline
- Start
- 2003-01
- Primary completion
- —
- Completion
- 2004-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 90 mg/kg | — |
| Subject | Azithromycin | Small molecule | 60 mg/kg | — |
| Subject | Clavulanate | Unknown | 6.4 mg/kg | — |