Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia

Phase 3

Completed

• Conditions: Bacterial Pneumonia

• Registration Number: NCT00080496
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2004-04-05
• Study First Submitted QC: 2004-04-06
• Study First Posted: 2004-04-07
• Study Completion: 2006-12
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-31
• Last Update Posted: 2008-08-04

Recruitment & Eligibility

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

Inclusion Criteria

• Male or female subjects over 18 years of age. Bulgaria Only: Male or female subjects over 18 years of age and under 70 years of age.
• Subjects known or suspected to have acute hospital-acquired pneumonia.

Exclusion Criteria

• Presence of any of the following pulmonary conditions: cystic fibrosis; pulmonary malignancy (either primary or metastatic); known bronchial-obstructive or post obstructive pneumonia; pulmonary abscess; empyema; known or suspected active tuberculosis; bronchiectasis; sarcoidosis; known or suspected pulmonary infection caused by Pneumocystis carinii, mycobacteria, fungi, parasites, or viruses (Subjects with COPD are not excluded)
• Suspected or known Legionella infection
• Concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The co-primary efficacy endpoints are clinical response at the TOC assessment for the clinically evaluable population and the clinical modified intent-to-treat population.