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

Infections Clinical Trial

Official title:

Evaluation of the Safety, Efficacy and Acceptability of HMR 3647 (20％ Fine Granules 1 g Sachet) in Children With Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408135
• Other study ID #: EFC6371
• Secondary ID: HMR3647B/3104
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2006
• Last updated: April 2, 2009
• Start date: August 2004
• Est. completion date: May 2005

Study information

• Verified date: April 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 16 Years

Eligibility

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

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

• Child
• Communicable Diseases
• Infection
• Infections

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 (abnormal changes of parameters in general hematological tests and blood biochemical tests).
Secondary	Clinical efficacy:change in the symptoms and signs at end of therapy visit and at the test of cure visit