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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00315549 |
This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups.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 Drug: Penicillin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Multinational, Randomized, Double Blind, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 800 mg od Versus 10 Days Penicillin V 500 mg Tid in Adolescent and Adult Subjects Equal to or Over 13 Years With Streptococcus Pyogenes Tonsillitis/Pharyngitis |
Estimated Enrollment: | 760 |
Study Start Date: | February 2006 |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Age equal to or over 13 years;
Subject is premenarchal or surgically incapable of bearing children,
Have normal menstrual flow within 1 month before study entry,
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:
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 Jose, Costa Rica |
Study ID Numbers: | EFC6134, HMR3647B/3006 |
Study First Received: | April 14, 2006 |
Last Updated: | March 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00315549 |
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 |
Penicillin V Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Tonsillitis |
Stomatognathic Diseases Pharyngitis Pharyngeal Diseases Telithromycin |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |