Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia

Condition(s) targeted: Community-Acquired Infections; Bacterial Pneumonia; Cross Infection

Intervention: Tigecycline (Drug); Levofloxacin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, MD, Study Director, Affiliation: Wyeth

To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.

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

Study design: Treatment, Randomized, Double-Blind, Safety/Efficacy Study

Primary outcome:

Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit.

Determine whether tigecycline is noninferior to levofloxacin.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female subjects ≥ 18 years of age and in Bulgaria only ≤ 70 years of age

- Subjects hospitalized with CAP with a severity that requires IV antibiotic treatment

for at least 7 days

- The presence of fever (within 24 hours before randomization)

Exclusion Criteria:

- Any concomitant condition that, in the opinion of the investigator, would preclude an

evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy <30 days).

- Hospitalization within 14 days before the onset of symptoms.

- Residence in a long-term care facility or nursing home ≥14 days before the onset of

symptoms.

Starting date: September 2003
Last updated: October 9, 2007