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

Phase 3

Completed

• Conditions: Community-Acquired Infections; Bacterial Pneumonia; Cross Infection

• Registration Number: NCT00081575
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2004-04-15
• Study First Submitted QC: 2004-04-16
• Study First Posted: 2004-04-19
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 434

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.