Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia

Phase 3TerminatedNCT01853982

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)4 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ventilator-Associated Pneumonia (VAP)

Interventions

Ceftolozane/TazobactamDRUG

Piperacillin/TazobactamDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (19)

Unnamed facility

Jacksonville, Florida, United States

Unnamed facility

Chicago, Illinois, United States

Unnamed facility

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Clinical Response at the End of Therapy Visit

Time frame: 24 hours after last dose of study drug

Data from ClinicalTrials.gov

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