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 treatment of ventilator-associated pneumonia (VAP) in adult participants .
Brief Title
Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
Categories
Completion Date
Completion Date Type
Actual
Conditions
Ventilator-Associated Pneumonia (VAP)
Eligibility 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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01853982
Org Class
Industry
Org Full Name
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Org Study Id
7625A-009
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Measure
Clinical Response at the End of Therapy Visit
Outcome Time Frame
24 hours after last dose of study drug
Secondary Ids
Secondary Id
CXA-NP-11-08
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Paul Riska
Investigator Email
priska@montefiore.org
Investigator Phone
718-020-6494