Back to resultsStudy Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
Primary Purpose
Bacterial Pneumonia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tigecycline
Imipenem
Cilastatin
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Pneumonia focused on measuring Pneumonia
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
Sites / Locations
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00080496
First Posted
April 5, 2004
Last Updated
July 31, 2008
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00080496
Brief Title
Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
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 Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Pneumonia
Keywords
Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
430 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tigecycline
Intervention Type
Drug
Intervention Name(s)
Imipenem
Intervention Type
Drug
Intervention Name(s)
Cilastatin
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251-6403
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260-6709
Country
United States
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States
City
Modesto
State/Province
California
ZIP/Postal Code
95350
Country
United States
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34428
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32601
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5300
Country
United States
City
Henderson
State/Province
North Carolina
ZIP/Postal Code
27536
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43071
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18436554
Citation
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. doi: 10.1093/jac/dkn165. Epub 2008 Apr 24.
Results Reference
derived
Learn more about this trial
Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
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