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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00080496
Recruitment Status : Completed
First Posted : April 7, 2004
Last Update Posted : August 4, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Bacterial Pneumonia Drug: Tigecycline Drug: Imipenem Drug: Cilastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : July 2003
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia




Primary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080496


Locations
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United States, Arizona
Phoenix, Arizona, United States, 85006
Phoenix, Arizona, United States, 85013
Scottsdale, Arizona, United States, 85251-6403
Scottsdale, Arizona, United States, 85260-6709
United States, California
Martinez, California, United States, 94553
Modesto, California, United States, 95350
Modesto, California, United States, 95355
National City, California, United States, 91950
United States, Florida
Bay Pines, Florida, United States, 33744
Crystal River, Florida, United States, 34428
Gainesville, Florida, United States, 32601
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta, Georgia, United States, 30342
Augusta, Georgia, United States, 30909
Roswell, Georgia, United States, 30076
United States, Illinois
Chicago, Illinois, United States, 60610
Springfield, Illinois, United States, 62769
Springfield, Illinois, United States, 62781
United States, Louisiana
New Orleans, Louisiana, United States, 70112
Shreveport, Louisiana, United States, 71103
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Missouri
Columbia, Missouri, United States, 65212
United States, Nebraska
Omaha, Nebraska, United States, 68198-5300
United States, North Carolina
Henderson, North Carolina, United States, 27536
United States, Ohio
Cincinnati, Ohio, United States, 45219
Zanesville, Ohio, United States, 43071
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19102
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00080496    
Other Study ID Numbers: 3074A1-311
First Posted: April 7, 2004    Key Record Dates
Last Update Posted: August 4, 2008
Last Verified: July 2008
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Pneumonia
Additional relevant MeSH terms:
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Pneumonia, Bacterial
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Imipenem
Tigecycline
Cilastatin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors