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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Pneumonia

Treatments: Drug: Telithromycin (HMR3647)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00638859

HMR3647B/3101

EFC6369

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 6 months to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)