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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
History of Changes

December 5, 2006
April 2, 2009
August 2004
May 2005   (final data collection date for primary outcome measure)
Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings (abnormal changes of parameters in general hematological tests and blood biochemical tests).
Same as current
Complete list of historical versions of study NCT00408135 on ClinicalTrials.gov Archive Site
Clinical efficacy:change in the symptoms and signs at end of therapy visit and at the test of cure visit
Same as current
Not Provided
Not Provided
 
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections
Evaluation of the Safety, Efficacy and Acceptability of HMR 3647 (20％ Fine Granules 1 g Sachet) in Children With Infections

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infections
  • Child
Drug: telithromycin (HMR3647)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
May 2005
May 2005   (final data collection date for primary outcome measure)

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
Both
6 Months to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00408135
EFC6371, HMR3647B/3104
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Norifumi Yamamoto sanofi-aventis Japan
Sanofi
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP