NCT00079885

Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia

A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment of subjects with CAP requiring hospitalization. The co-primary efficacy endpoints in the study will be the clinical response in the clinically evaluable population and the clinical response in the clinical modified intent-to-treat population at the TOC visit. The primary efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. If tigecycline is found to be noninferior, the analyses will determine whether tigecycline is statistically better than levofloxacin.

Conditions

• Community Acquired Pneumonia
• Bacterial Pneumonia
• Cross Infection

Interventions

Type	Name	Description
DRUG	tigecycline

Timeline

• Start date: 2003-11-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2004-03-19
• Last updated: 2013-02-08