Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
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
1 other identifier
interventional
430
1 country
29
Brief Summary
To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2003
Typical duration for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 5, 2004
CompletedFirst Posted
Study publicly available on registry
April 7, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedAugust 4, 2008
July 1, 2008
April 5, 2004
July 31, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Unknown Facility
Phoenix, Arizona, 85006, United States
Unknown Facility
Phoenix, Arizona, 85013, United States
Unknown Facility
Scottsdale, Arizona, 85251-6403, United States
Unknown Facility
Scottsdale, Arizona, 85260-6709, United States
Unknown Facility
Martinez, California, 94553, United States
Unknown Facility
Modesto, California, 95350, United States
Unknown Facility
Modesto, California, 95355, United States
Unknown Facility
National City, California, 91950, United States
Unknown Facility
Bay Pines, Florida, 33744, United States
Unknown Facility
Crystal River, Florida, 34428, United States
Unknown Facility
Gainesville, Florida, 32601, United States
Unknown Facility
Orlando, Florida, 32806, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Augusta, Georgia, 30909, United States
Unknown Facility
Roswell, Georgia, 30076, United States
Unknown Facility
Chicago, Illinois, 60610, United States
Unknown Facility
Springfield, Illinois, 62769, United States
Unknown Facility
Springfield, Illinois, 62781, United States
Unknown Facility
New Orleans, Louisiana, 70112, United States
Unknown Facility
Shreveport, Louisiana, 71103, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Columbia, Missouri, 65212, United States
Unknown Facility
Omaha, Nebraska, 68198-5300, United States
Unknown Facility
Henderson, North Carolina, 27536, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Zanesville, Ohio, 43071, United States
Unknown Facility
Philadelphia, Pennsylvania, 19102, United States
Unknown Facility
Philadelphia, Pennsylvania, 19140, United States
Unknown Facility
Greenville, South Carolina, 29605, United States
Related Publications (1)
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.
PMID: 18436554DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 5, 2004
First Posted
April 7, 2004
Study Start
July 1, 2003
Study Completion
December 1, 2006
Last Updated
August 4, 2008
Record last verified: 2008-07