NCT00174694

CHOOSE : Telithromycin, Acute Bacterial Sinusitis

A Prospective, Randomized, Open-label, Active-controlled Study in Adult Subjects With Acute Bacterial Sinusitis Comparing the Clinical Efficacy of Telithromycin (KETEK®) 800 mg Once a Day for 5 Days Versus Amoxicillin-clavulanic Acid (AUGMENTIN®) 875/125 mg Twice a Day for 10 Days

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: * To demonstrate that the clinical efficacy of telithromycin (800 mg od for 5 days) is non-inferior to amoxicillin-clavulanic acid (875/125 mg bid for 10 days) at the test-of-cure (TOC) visit (Day 17-21) in subjects with acute bacterial sinusitis (ABS). Secondary objective(s): * To assess the time to resolution of signs and symptoms between the baseline (Day 1) and TOC (Day 17-21) visits, * To assess the rate of clinical relapse at the follow-up visit (Day 41-49), * To assess health economic outcome until follow-up visit (Day 41-49), * To assess quality of life up to the follow-up visit (Day 41-49), * To compare the safety of telithromycin and amoxicillin-clavulanic acid, * To compare the bacteriologic outcome of both treatments as observed at TOC (Day 17-21) and at follow-up visit (Day 41-49),in subjects with ABS.

Conditions

• Sinusitis

Interventions

Type	Name	Description
DRUG	Telithromycin

Timeline

• Start date: 2004-11-01
• Primary completion: 2005-12-01
• First posted: 2005-09-15
• Last updated: 2009-09-25