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

Bacterial Pneumonia Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Imipenem/Cilastatin For The Treatment Of Subjects With Nosocomial Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080496
• Other study ID #: 3074A1-311
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2004
• Last updated: July 31, 2008
• Start date: July 2003
• Est. completion date: December 2006

Study information

• Verified date: July 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Tigecycline

• Imipenem

• Cilastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.