drugset / Trial / NCT00645112

A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

NCT00645112

Phase 4 Completed 357 enrolled Abbott
RandomizedParallel-groupSingle-blindTreatment

Summary

To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.

Timeline

Start
2003-11
Primary completion
2004-01
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azithromycin Small molecule 5 mg/kg Oral
Comparator cefdinir Other / unclassified 7 mg/kg Oral

Indications