NCT00315549

TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tonsillitis
• Pharyngitis

Interventions

Type	Name	Description
DRUG	Telithromycin
DRUG	Penicillin

Timeline

• Start date: 2006-02-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2006-04-18
• Last updated: 2009-04-03

Locations

4 sites across 4 countries: United States, Argentina, Chile, Costa Rica