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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00080496
First received: April 5, 2004
Last updated: July 31, 2008
Last verified: July 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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 is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Pneumonia

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cilastatin
Imipenem
 Tigecycline
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013