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

July 31, 2008 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

430

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
      • Phoenix, Arizona, United States, 85006
      • Scottsdale, Arizona, United States, 85251-6403
      • Scottsdale, Arizona, United States, 85260-6709
    • California
      • Martinez, California, United States, 94553
      • Modesto, California, United States, 95350
      • Modesto, California, United States, 95355
      • National City, California, United States, 91950
    • Florida
      • Bay Pines, Florida, United States, 33744
      • Crystal River, Florida, United States, 34428
      • Gainesville, Florida, United States, 32601
      • Orlando, Florida, United States, 32806
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Augusta, Georgia, United States, 30909
      • Roswell, Georgia, United States, 30076
    • Illinois
      • Chicago, Illinois, United States, 60610
      • Springfield, Illinois, United States, 62769
      • Springfield, Illinois, United States, 62781
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
      • Shreveport, Louisiana, United States, 71103
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Missouri
      • Columbia, Missouri, United States, 65212
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5300
    • North Carolina
      • Henderson, North Carolina, United States, 27536
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Zanesville, Ohio, United States, 43071
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
      • Philadelphia, Pennsylvania, United States, 19102
    • South Carolina
      • Greenville, South Carolina, United States, 29605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

April 5, 2004

First Submitted That Met QC Criteria

April 6, 2004

First Posted (Estimate)

April 7, 2004

Study Record Updates

Last Update Posted (Estimate)

August 4, 2008

Last Update Submitted That Met QC Criteria

July 31, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3074A1-311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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