Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174694
Status:
COMPLETED
Last Update Posted:
2009-09-25
First Post:
2005-09-09
Brief Title:
CHOOSE Telithromycin Acute Bacterial Sinusitis
Sponsor:
Sanofi
Organization:
Sanofi
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 875125 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 875125 mg bid for 10 days at the test-of-cure TOC visit Day 17-21 in subjects with acute bacterial sinusitis ABS
Secondary objectives
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 41-49in subjects with ABS
To demonstrate that the clinical efficacy of telithromycin 800 mg od for 5 days is non-inferior to amoxicillin-clavulanic acid 875125 mg bid for 10 days at the test-of-cure TOC visit Day 17-21 in subjects with acute bacterial sinusitis ABS
Secondary objectives
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 41-49in subjects with ABS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2004-001460-42 | None | None | None |