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

NCT ID: NCT00638859

Last Updated: 2009-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-10-31

Brief Summary

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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

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Conditions

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Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Telithromycin (HMR3647)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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HMR3647B/3101

Identifier Type: -

Identifier Source: secondary_id

EFC6369

Identifier Type: -

Identifier Source: org_study_id

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