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

Phase 3

Completed

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

• Registration Number: NCT00079885
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2004-03-18
• Study First Submitted QC: 2004-03-18
• Study First Posted: 2004-03-19
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

• Male and female subjects ≥ 18 years of ag.
• Subjects hospitalized with CAP for whom IV antibiotic treatment is indicated
• The presence of fever (within 24 hours prior to randomization), defined as oral temperature >38°C/100.4°F, axillary temperature >38.1°C/100.6°F, tympanic temperature >38.5°C/ 101.2°F, or a rectal/core temperature >39°C/102.2°F OR hypothermia (within 24 hours prior to randomization), core temperature <35°C/95°

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 prior to 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