Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections
NCT00174811 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 639
Last updated 2009-04-03
Summary
The clinical activity of telithromycin vs. cefuroxime in children with acute infections of the middle ear, ages 6 months to 59 months old will be studied.
Conditions
- Otitis Media
Interventions
- DRUG
-
telithromycin (HMR3647)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ICD CSD · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 59 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-06-30
- Primary Completion
- 2006-06-30
- Completion
- 2006-06-30
Countries
- United States
- France
Study Locations
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