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

Sanofi56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pneumonia

Interventions

Telithromycin (HMR3647)DRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis

Tokyo, Japan

Outcomes

Primary Outcomes

Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings

Secondary Outcomes

Clinical efficacy: change in the symptoms and signs

Acceptability: compliance and willingness to take medication

Pharmacokinetics: plasma concentrations of telithromycin

Data from ClinicalTrials.gov

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