CHOOSE : Telithromycin, Acute Bacterial Sinusitis

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.

Timeline

Start

2004-11

Primary completion

2005-12

Completion

—

Outcome

Met primary endpoint

paper The per-protocol clinical success rate (primary endpoint) with telithromycin (88.6% (109/123)) was noninferior to that with amoxicillin-clavulanate (88.8% (111/125)) (95% confidence interval: -8.9 to 8.5). PMID 18559163 ↗

Publications

• Results Desrosiers M, Ferguson B, Klossek JM, Drugeon H, Mosges R. Clinical efficacy and time to symptom resolution of 5-day telithromycin versus 10-day amoxicillin-clavulanate in the treatment of acute bacterial sinusitis. Curr Med Res Opin. 2008 Jun;24(6):1691-702. doi: 10.1185/03007990802133914.

Drugs

Indications