TELI COM - Telithromycin in Children With Otitis Media
Status:
Terminated
Trial end date:
2006-07-01
Target enrollment:
Participant gender:
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.