Overview

Telithromycin in Respiratory Tract Infections

Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
Participant gender:
Summary
Primary Objectives: - The primary objective of the study is to evaluate clinical efficacy i.e. to show that with respect to clinical cure rate, Ketek® (telithromycin) in the treatment of community acquired respiratory tract infections: community acquired pneumonia (CAP), acute bacterial exacerbation of chronic bronchitis (AECB) and acute sinusitis (AS), in outpatients. Secondary Objectives: The secondary objectives are to: - Further assess the efficacy of Ketek® (telithromycin) by considering the rate at which additional antibacterials were prescribed to treat the primary infection; the rate of hospitalisation due to a complication of the primary infection and assessment of bacteriological data, chest X-ray and sinus X-ray if available. - Evaluate safety of Ketek® (telithromycin) through Adverse Event (AE) and Serious Adverse Event (SAE) reporting
Phase:
Phase 4
Details
Lead Sponsor:
Sanofi
Treatments:
Telithromycin