Status:
TERMINATED
Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Ventilator-Associated Pneumonia (VAP)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV piperacillin/tazobactam in the ...
Eligibility Criteria
Inclusion
- Key
- Participant has received mechanical ventilation for \> 48 hours
- Acute Physiology and Chronic Health Evaluation (APACHE) II score of 11-35
- Presence of a new or progressive infiltrate on chest x-ray
- Presence of clinical criteria consistent with VAP
- Key
Exclusion
- History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics
- Known end stage renal disease or requirement for dialysis
Key Trial Info
Start Date :
June 14 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01853982
Start Date
June 14 2013
End Date
December 8 2013
Last Update
November 16 2018
Active Locations (19)
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1
Jacksonville, Florida, United States
2
Chicago, Illinois, United States
3
Baltimore, Maryland, United States
4
Duluth, Minnesota, United States