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

This study has been completed.

First Received: April 5, 2004 Last Updated: July 31, 2008 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00080496

Purpose

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

Condition	Intervention	Phase
Bacterial Pneumonia	Drug: Tigecycline Drug: Imipenem Drug: Cilastatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Imipenem Cilastatin sodium Cilastatin Tigecycline

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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.

Estimated Enrollment:	430
Study Start Date:	July 2003
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080496

Show 29 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided by Wyeth

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Karageorgopoulos DE, Kelesidis T, Kelesidis I, Falagas ME. Tigecycline for the treatment of multidrug-resistant (including carbapenem-resistant) Acinetobacter infections: a review of the scientific evidence. J Antimicrob Chemother. 2008 Jul;62(1):45-55. Epub 2008 Apr 24.

Study ID Numbers:	3074A1-311
Study First Received:	April 5, 2004
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00080496 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Pneumonia

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Tigecycline
Enzyme Inhibitors
Pharmacologic Actions
Imipenem
Protease Inhibitors

Anti-Bacterial Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Pneumonia, Bacterial
Lung Diseases
Cilastatin
Pneumonia

ClinicalTrials.gov processed this record on November 09, 2009