NCT00315003

TELI COM - Telithromycin in Children With Otitis Media

Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 25mg/kg od Versus 5 Days Azithromycin 10 mg/kg od Followed by 5 mg/kg od for 4 Days, in Children With Acute Otitis Media

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,500 (planned)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Not accepted

Summary

This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and \<72 months \[\< 6 years of age\]) with AOM.Subjects will be randomized to receive either telithromycin (50 mg/mL) oral suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/mL) oral suspension (10 mg/kg once on Day 1, followed by 5 mg/kg once daily on Days 2-5, not to exceed 500 mg onDay 1 and 250 mg/day from Days 2 - 5. Matching placebo suspensions for telithromycin and azithromycin will also be dispensed to provide blinding for the different treatment regimens.Assessments and reporting of safety will be carried out at all visits.

Conditions

• Otitis Media, Suppurative
• Otitis Media, Purulent

Interventions

Type	Name	Description
DRUG	Telithromycin
DRUG	Azithromycin

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2006-04-17
• Last updated: 2009-04-03

Locations

13 sites across 13 countries: United States, Argentina, Brazil, Canada, Chile, Colombia, Costa Rica, Czechia, Dominican Republic, Guatemala, Israel, Panama, Peru