Trials / Terminated
TerminatedNCT00174811
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
Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of Telithromycin 25 mg/kg Given Once Daily for 5 or 10 Days Depending on Age and Previous Treatment History Versus Cefuroxime Axetil 15 mg/kg, Given Twice Daily for 10 Days, in Children With Acute Otitis Media
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 639 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 6 Months – 59 Months
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | telithromycin (HMR3647) |
Timeline
- Start date
- 2005-06-01
- Primary completion
- 2006-06-01
- Completion
- 2006-06-01
- First posted
- 2005-09-15
- Last updated
- 2009-04-03
Locations
2 sites across 2 countries: United States, France
Source: ClinicalTrials.gov record NCT00174811. Inclusion in this directory is not an endorsement.