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Clinical Trials/NCT01853982
NCT01853982
Terminated
Phase 3

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

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)0 sites4 target enrollmentJune 14, 2013
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ConditionsVentilator-Associated Pneumonia (VAP)
InterventionsCeftolozane/TazobactamPiperacillin/Tazobactam
DrugsCeftolozane/TazobactamPiperacillin/Tazobactam

Overview

Phase
Phase 3
Intervention
Ceftolozane/Tazobactam
Conditions
Ventilator-Associated Pneumonia (VAP)
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Enrollment
4
Primary Endpoint
Clinical Response at the End of Therapy Visit
Status
Terminated
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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 .

Registry
clinicaltrials.gov
Start Date
June 14, 2013
End Date
December 8, 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Responsible Party
Sponsor

Eligibility 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

Exclusion Criteria

  • •History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics
  • •Known end stage renal disease or requirement for dialysis

Arms & Interventions

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

Intervention: Ceftolozane/Tazobactam

Piperacillin/Tazobactam

4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days

Intervention: Piperacillin/Tazobactam

Outcomes

Primary Outcomes

Clinical Response at the End of Therapy Visit

Time Frame: 24 hours after last dose of study drug

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