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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00315042 |
This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.
Condition | Intervention | Phase |
---|---|---|
Tonsillitis Pharyngitis |
Drug: Telithromycin (HMR3647) Drug: Penicillin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Multinational, Randomized, Double-Blind, Double Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 25mg/kg od Versus 10 Days Penicillin V 13.3 mg/kg Tid in Children 6 Months to Less Than 13 Years With Streptococcus Pyogenes Tonsillitis/Pharyngitis |
Enrollment: | 314 |
Study Start Date: | March 2006 |
Study Completion Date: | August 2006 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Months to 13 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on:
A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs:
Exclusion Criteria:
The subject:
United States, New Jersey | |
Sanofi-Aventis | |
Bridgewater, New Jersey, United States, 08807 | |
Argentina, Buenos Aires | |
Sanofi-Aventis | |
San Isidro, Buenos Aires, Argentina, 1642 | |
Chile, Santiago | |
Sanofi-Aventis | |
Providencia, Santiago, Chile | |
Costa Rica | |
Sanofi-Aventis | |
San José, Costa Rica | |
Panama | |
Sanofi-Aventis | |
Panama, Panama |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC6133, HMR3647B/3004 |
Study First Received: | April 13, 2006 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00315042 History of Changes |
Health Authority: | United States: Food and Drug Administration; Chile: Instituto de Salud Publica de Chile; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Tonsillitis pharyngitis penicillin |
telithromycin ketolides clinical trials |
Anti-Bacterial Agents Penicillin V Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Tonsillitis Stomatognathic Diseases Pharyngitis Pharyngeal Diseases Telithromycin |
Anti-Infective Agents Anti-Bacterial Agents Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses |
Tonsillitis Stomatognathic Diseases Pharyngitis Pharyngeal Diseases Pharmacologic Actions Telithromycin |