Status:
COMPLETED
Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Bacterial Pneumonia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT00080496
Start Date
July 1 2003
End Date
December 1 2006
Last Update
August 4 2008
Active Locations (29)
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1
Phoenix, Arizona, United States, 85006
2
Phoenix, Arizona, United States, 85013
3
Scottsdale, Arizona, United States, 85251-6403
4
Scottsdale, Arizona, United States, 85260-6709