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CHOOSE : Telithromycin, Acute Bacterial Sinusitis

NCT00174694 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2009-09-25

No results posted yet for this study

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

DRUG

Telithromycin

Sponsors & Collaborators

Principal Investigators

  • Gilles Perdriset, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2005-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00174694 on ClinicalTrials.gov