Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT00174694
Status:
COMPLETED
Last Update Posted:
2009-09-25
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CHOOSE : Telithromycin, Acute Bacterial Sinusitis
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EudraCT # : 2004-001460-42 | None | None | View |