Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia
Phase 3
Completed
- Conditions
- Pneumonia
- Registration Number
- NCT00638859
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
- Secondary Outcome Measures
Name Time Method Clinical efficacy: change in the symptoms and signs Acceptability: compliance and willingness to take medication Pharmacokinetics: plasma concentrations of telithromycin
Trial Locations
- Locations (1)
Sanofi-Aventis
🇯🇵Tokyo, Japan