NCT00643149

A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children

A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial Of Azithromycin SR Versus Amoxicillin For The Treatment Of Group A Β-Hemolytic Streptococcal Pharyngitis/Tonsillitis In Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 693 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.

Conditions

• Tonsillitis

Interventions

Type	Name	Description
DRUG	amoxicillin	10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
DRUG	azithromycin SR	60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin when used to treat children with strep throat

Timeline

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

Locations

46 sites across 5 countries: United States, Canada, Costa Rica, Guatemala, India