Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT00174694
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.
Study:
NCT00174694
Study Brief:
Protocol Section:
NCT00174694