Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
Information source: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ventilator-Associated Pneumonia (VAP)
Intervention: Ceftolozane/Tazobactam (Drug); Piperacillin/Tazobactam (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Cubist Pharmaceuticals Holdings LLC Official(s) and/or principal investigator(s):
Obiamiwe Umeh, MD, Study Director, Affiliation: Cubist Pharmaceuticals
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 treatment of ventilator-associated pneumonia (VAP) in adult
participants .
Clinical Details
Official title: A Multicenter, Open-Label, Randomized Study to Compare the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam With That of Piperacillin/Tazobactam in Ventilator Associated Pneumonia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical Response at the End of Therapy Visit
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Key Inclusion Criteria:
- 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 Criteria:
- History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics
- Known end stage renal disease or requirement for dialysis
Locations and Contacts
Auckland, New Zealand
Christchurch, New Zealand
Wellington, New Zealand
Jacksonville, Florida, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Duluth, Minnesota, United States
Omaha, Nebraska, United States
Bronx, New York, United States
Jamaica, New York, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Abington, Pennsylvania, United States
Herston, Queensland, Australia
Meadowbrook, Queensland, Australia
Nambour, Queensland, Australia
Southport, Queensland, Australia
Woolloongabba, Queensland, Australia
Nashville, Tennessee, United States
Additional Information
Starting date: July 2013
Last updated: July 24, 2015
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