TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults
Status:
Terminated
Trial end date:
2006-09-01
Target enrollment:
Participant gender:
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.