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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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