drugset / Trial / NCT00643539

Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat

NCT00643539

Phase 4 Completed 360 enrolled Pfizer
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15 years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.

Timeline

Start
2002-12
Primary completion
Completion
2003-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 25 mg/kg Oral
Subject Azithromycin Small molecule 20 mg/kg Oral

Indications