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
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|ClinicalTrials.gov Identifier: NCT00174811|
Recruitment Status : Terminated (Pediatric development program terminated by sponsor)
First Posted : September 15, 2005
Last Update Posted : April 3, 2009
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media||Drug: telithromycin (HMR3647)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||639 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||June 2005|
|Primary Completion Date :||June 2006|
|Study Completion Date :||June 2006|
- Clinical cure at the posttherapy/test-of-cure (TOC) Visit 3 (Day 13-17).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174811
|United States, New Jersey|
|Sanofi-Aventis Administrative Office|
|Bridgewater, New Jersey, United States, 08807|
|Sanofi- Aventis Administrative Office|
|Study Director:||ICD CSD||Sanofi|