Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections
|ClinicalTrials.gov Identifier: NCT00408135|
Recruitment Status : Completed
First Posted : December 6, 2006
Last Update Posted : April 3, 2009
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 or disease||Intervention/treatment||Phase|
|Infections Child||Drug: telithromycin (HMR3647)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Safety, Efficacy and Acceptability of HMR 3647 (20％ Fine Granules 1 g Sachet) in Children With Infections|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
- Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings (abnormal changes of parameters in general hematological tests and blood biochemical tests).
- Clinical efficacy:change in the symptoms and signs at end of therapy visit and at the test of cure visit
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408135
|Study Director:||Norifumi Yamamoto||sanofi-aventis Japan|