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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00408135
First received: December 5, 2006
Last updated: April 2, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Infections
Child
Drug: telithromycin (HMR3647)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Safety, Efficacy and Acceptability of HMR 3647 (20% Fine Granules 1 g Sachet) in Children With Infections

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • Clinical efficacy:change in the symptoms and signs at end of therapy visit and at the test of cure visit

Enrollment: 111
Study Start Date: August 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408135

Locations
Japan
Sanofi-Aventis
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Norifumi Yamamoto sanofi-aventis Japan
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00408135     History of Changes
Other Study ID Numbers: EFC6371, HMR3647B/3104
Study First Received: December 5, 2006
Last Updated: April 2, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:
Respiratory Tract Infections
Skin Diseases
Sinusitis

Additional relevant MeSH terms:
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014