drugset / Trial / NCT00408135

Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections

NCT00408135

Phase 3 Completed 111 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules) 1g filling sachet in children with infections (Respiratory tract infections, Dermatological infections, Otorhinolaryngological infections, Dentistry/Oral surgery infections). Secondary objectives are to assess the clinical efficacy, bacteriological efficacy and acceptability of telithromycin (20% fine granules) 1g filling sachet in children with infections.

Timeline

Start
2004-08
Primary completion
2005-05
Completion
2005-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Telithromycin Small molecule 1 g

Indications