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

Sponsored by:	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

MedlinePlus related topics: Pneumonia

Drug Information available for: Tigecycline Cilastatin Cilastatin sodium Imipenem

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

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.

Eligibility

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

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Publications indexed to this study:

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

Keywords provided by Wyeth:

Pneumonia

Study placed in the following topic categories:

Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Tigecycline
Cilastatin

Lung Diseases
Pneumonia, Bacterial
Pneumonia
Imipenem

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009