NCT00315042

TELI TON - Telithromycin in Tonsillitis

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Months – 13 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tonsillitis
• Pharyngitis

Interventions

Type	Name	Description
DRUG	Telithromycin (HMR3647)
DRUG	Penicillin

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2006-04-17
• Last updated: 2009-04-03

Locations

5 sites across 5 countries: United States, Argentina, Chile, Costa Rica, Panama