NCT00132938

PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis

An Open-label, Randomized, Multicenter, Clinical Study to Compare the Effects of Telithromycin, Azithromycin and Cefuroxime Axetil on the Penicillin or Macrolide Resistance of Streptococcus Pneumoniae in Patients With Acute Exacerbation of Chronic Bronchitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5,660 (planned)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: * The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit 1). Secondary Objectives: The secondary objectives of the study are: * To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study (Visit 1); * To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp (SSp) population at the End of Therapy (EOT) and Test of Cure visits; * To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study (Visit 1); * To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin, azithromycin and cefuroxime axetil in the "global" randomized population.

Conditions

• Chronic Bronchitis

Interventions

Type	Name	Description
DRUG	telithromycin

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2005-08-22
• Last updated: 2011-06-08

Locations

8 sites across 8 countries: United States, Belgium, France, Hungary, Morocco, Spain, Tunisia, Turkey (Türkiye)