CHOOSE : Telithromycin, Acute Bacterial Sinusitis

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Sinusitis

Clinical Trial Details

NCT number	NCT00174694
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 4
Start date	November 2004

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03584178` - The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis	N/A
Completed	`NCT06016335` - MRI-based Synthetic CT Images of the Head and Neck	N/A
Active, not recruiting	`NCT02278484` - Sinus Balloon Dilation in Pediatric Patients	N/A
Withdrawn	`NCT02071667` - Association of Periostin Levels and Chronic Sinusitis	N/A
Completed	`NCT01420471` - Medicated Punctured-Glove-Finger Spacer Study	Phase 4
Completed	`NCT01118312` - Study of Asthma and Nasal Steroids	Phase 4
Completed	`NCT00645762` - Balloon REmodeling Antrostomy THErapy Study	Phase 2
Completed	`NCT01685229` - Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
Active, not recruiting	`NCT03943121` - The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps	N/A
Withdrawn	`NCT02900794` - Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery	N/A
Terminated	`NCT02630472` - Topical Irrigation Therapy for CRS	Phase 1/Phase 2
Completed	`NCT01442740` - 15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients	N/A
Completed	`NCT01001039` - Validation of the Facial and Cephalic Pain Inventory	N/A
Completed	`NCT01033799` - Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers	N/A
Completed	`NCT00335309` - Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis	N/A
Completed	`NCT00242437` - Hemostatic Matrix in Endoscopic Sinus Surgery	Phase 4
Completed	`NCT00236522` - A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.	Phase 3
Completed	`NCT01717274` - Hot Saline Irrigation Study	N/A
Completed	`NCT01166945` - Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children	N/A
Completed	`NCT00747747` - Sinuclean's Treatment Of Sinusitis' Symptoms	Phase 4