Clinical Trial: TELI COM - Telithromycin in Children With Otitis Media

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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/

Brief 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.

Detailed Summary:
Sponsor: Sanofi

Current Primary Outcome: The primary efficacy variables will be time to symptom resolution (TSR) and clinical cure at theposttherapy/TOC Visit 3.

Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse events (AEs) reported by subjects, their parents/legally authorized representative, orobserved by the investigators will be recorded throughout the study.

Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: April 13, 2006
Date Started: January 2006
Date Completion:
Last Updated: April 2, 2009
Last Verified: April 2009