Status:
COMPLETED
Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia
Lead Sponsor:
Sanofi
Conditions:
Pneumonia
Eligibility:
All Genders
6-16 years
Phase:
PHASE3
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 Pharmacokinet...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00638859
Start Date
March 1 2004
End Date
October 1 2004
Last Update
October 2 2009
Active Locations (1)
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1
Sanofi-Aventis
Tokyo, Japan