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NCT00638859 Clinical Trial

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

Pneumonia Clinical Trial

Official title:
Evaluation of the Safety, Pharmacokinetics, Efficacy, and Acceptability of HMR3647 20 mg/kg qd for 5-7 Days With Community-Acquired Pneumonia (CAP) in Children (Multicenter, Open Label, Noncomparative Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00638859
Other study ID # EFC6369
Secondary ID HMR3647B/3101
Status Completed
Phase Phase 3
First received March 12, 2008
Last updated October 1, 2009
Start date March 2004
Est. completion date October 2004

Study information
Verified date October 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date October 2004
Est. primary completion date October 2004
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 16 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Telithromycin (HMR3647)

Locations
Country Name City State
Japan Sanofi-Aventis Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
Secondary Clinical efficacy: change in the symptoms and signs
Secondary Acceptability: compliance and willingness to take medication
Secondary Pharmacokinetics: plasma concentrations of telithromycin
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