Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
Phase 3
Terminated
- Conditions
- Ventilator-Associated Pneumonia (VAP)
- Interventions
- Drug: Piperacillin/Tazobactam
- Registration Number
- NCT01853982
- Lead Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- 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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ceftolozane/Tazobactam Ceftolozane/Tazobactam 3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days Piperacillin/Tazobactam Piperacillin/Tazobactam 4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
- Primary Outcome Measures
Name Time Method Clinical Response at the End of Therapy Visit 24 hours after last dose of study drug
- Secondary Outcome Measures
Name Time Method