Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5-7 days in children with community-acquired pneumonia (CAP).

Secondary objectives are to assess Pharmacokinetics, Efficacy and Acceptability of telithromycin 20 mg/kg qd for 5-7 days in children with CAP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Telithromycin

Criteria

Inclusion Criteria:

• Subjects who are weighing 40 kg or less. If female, premenarchal status is required.

• Subjects who are diagnosed with CAP based on chest X-ray showing the presence of a new infiltrate, clinical symptoms, and laboratory findings.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.