NCT00132951

KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections

A Randomized, Investigator Blinded, Multi-Center Clinical Study To Compare Patient Outcomes and Clinical Effectiveness of Telithromycin Versus Azithromycin in Outpatients With Lower Respiratory Tract Infections

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,051 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if 1 course of antibiotic treatment with telithromycin is superior to azithromycin in the treatment of lower respiratory tract infections (LRTIs), acute exacerbations of chronic bronchitis (AECBs) and community-acquired pneumonia (CAP) in the community setting.

Conditions

• Respiratory Tract Infections
• Chronic Bronchitis
• Pneumonia

Interventions

Type	Name	Description
DRUG	Telithromycin	Telithromycin (AECB: 2 tablets per day for Days 1-5; CAP: 2 tablets per day for Days 1-7)
DRUG	Azithromycin	Azithromycin (AECB: 2 tablets on Day 1 then 1 tablet + 1 placebo tablet per day for Days 2-5; CAP: 2 tablets on Day 1 then 1 tablet + 1 placebo tablet per day for Days 2-5 then 2 placebo tablets per day for Days 6-7)

Timeline

• Start date: 2004-10-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2005-08-22
• Last updated: 2009-08-27

Locations

2 sites across 2 countries: United States, Canada