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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: March 18, 2004
Date Started: November 2003
Date Completion:
Last Updated: February 7, 2013
Last Verified: February 2013