Status:
COMPLETED
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections
Lead Sponsor:
Sanofi
Conditions:
Infections
Child
Eligibility:
All Genders
6-16 years
Phase:
PHASE3
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, Ot...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00408135
Start Date
August 1 2004
End Date
May 1 2005
Last Update
April 3 2009
Active Locations (1)
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1
Sanofi-Aventis
Tokyo, Japan