Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections

Phase 3

Completed

• Conditions: Infections; Child

• Registration Number: NCT00408135
• Lead Sponsor: Sanofi

Brief Summary

The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules) 1g filling sachet in children with infections (Respiratory tract infections, Dermatological infections, Otorhinolaryngological infections, Dentistry/Oral surgery infections).

Secondary objectives are to assess the clinical efficacy, bacteriological efficacy and acceptability of telithromycin (20% fine granules) 1g filling sachet in children with infections.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Study First Submitted: 2006-12-05
• Study First Submitted QC: 2006-12-05
• Study First Posted: 2006-12-06
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-02
• Last Update Posted: 2009-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• Outpatients of weight from 7.0 kg.
• For respiratory tract infections:subjects diagnosed with mild or moderate respiratory tract infection (excluding pneumonia) based on a fever (≥ 38°C) or C-Reactive Protein positive, clinical symptoms/signs, and laboratory findings.
• For dermatological infections: subjects diagnosed with mild or moderate dermatological infection in terms of clinical symptoms/signs and laboratory findings.
• For otorhinolaryngological infections:subjects with purulent / mucopurulent rhinorrhea and postrhinorrhea, subjects diagnosed with mild or moderate otorhinolaryngological infection in terms of clinical symptoms/signs and laboratory findings
• For dental / oral surgical infections: subjects who have formed obstructive abscess and diagnosed with mild or moderate dental / oral surgical infection

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings (abnormal changes of parameters in general hematological tests and blood biochemical tests).

Secondary Outcome Measures

Name	Time	Method
Clinical efficacy:change in the symptoms and signs at end of therapy visit and at the test of cure visit

Trial Locations

Locations (1)

Sanofi-Aventis; 🇯🇵 Tokyo, Japan