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
This study has been terminated.
(Pediatric development program terminated by sponsor)
Information provided by:
First received: September 13, 2005
Last updated: April 2, 2009
Last verified: April 2009
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Clinical cure at the posttherapy/test-of-cure (TOC) Visit 3 (Day 13-17).
Secondary Outcome Measures:
- Time to symptom resolution (TSR).
- Clinical cure by protocol-defined causative pathogen isolated at baseline·
- Bacteriological eradication in population with protocol-defined causative pathogen isolated at baseline.
- Safety of telithromycin versus cefuroxime axetil.
- Plasma telithromycin concentrations during treatment in the subpopulation of subjects participating in the pharmacokinetic (PK) substudy.
- Health resource utilization and impact on usual activities.
|Study Start Date:||June 2005|
|Study Completion Date:||June 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174811
|United States, New Jersey|
|Sanofi-Aventis Administrative Office|
|Bridgewater, New Jersey, United States, 08807|
|Sanofi- Aventis Administrative Office|
Sponsors and Collaborators
|Study Director:||ICD CSD||Sanofi|