Back to resultsJapanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections
Primary Purpose
Infections, Child
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
telithromycin (HMR3647)
Sponsored by
About this trial
This is an interventional treatment trial for Infections focused on measuring Respiratory Tract Infections, Skin Diseases, Sinusitis
Eligibility 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
Sites / Locations
- Sanofi-Aventis
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00408135
Brief Title
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections
Official Title
Evaluation of the Safety, Efficacy and Acceptability of HMR 3647 (20％ Fine Granules 1 g Sachet) in Children With Infections
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Child
Keywords
Respiratory Tract Infections, Skin Diseases, Sinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
telithromycin (HMR3647)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Clinical efficacy:change in the symptoms and signs at end of therapy visit and at the test of cure visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norifumi Yamamoto
Organizational Affiliation
sanofi-aventis Japan
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections
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