NCT00645112

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Otitis Media

Interventions

Type	Name	Description
DRUG	cefdinir (Omnicef)	oral suspension, 7 mg/kg every 12 hours for 5 days
DRUG	azithromycin	oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days.

Timeline

• Start date: 2003-11-01
• Primary completion: 2004-01-01
• First posted: 2008-03-27
• Last updated: 2008-03-27

Locations

30 sites across 1 country: United States