Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)

• Status: Completed
• Trial end date: 2018-06-06
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 3, multicenter, prospective, randomized study of intravenous (IV) ceftolozane/tazobactam versus IV meropenem in the treatment of adult participants with either ventilator-associated bacterial pneumonia (VABP) or ventilated hospital-acquired bacterial pneumonia (HABP). The primary objective is to demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in adult participants with ventilated nosocomial pneumonia (VNP) based on the difference in Day 28 all-cause mortality rates in the Intent-to-treat (ITT) population using a non-inferiority margin of 10%.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Ceftolozane; Ceftolozane, tazobactam drug combination; Cephalosporins; Meropenem; Penicillanic Acid; Tazobactam; Thienamycins

Criteria

Key Inclusion Criteria:

• Adult participants diagnosed with either VABP or ventilated HABP requiring IV antibiotic therapy;

• Intubated and on mechanical ventilation at the time of randomization;

• New or progressive infiltrate on chest radiography consistent with pneumonia;

• Presence of clinical criteria consistent with a diagnosis of ventilated nosocomial pneumonia.

Key Exclusion Criteria:

• History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics;

• Prior non-study antibiotics for > 24 hours;

• Gram stain of lower respiratory tract specimen showing only gram positive bacteria;

• Active immunosuppression;

• End-stage renal disease or requirement for dialysis;

• Expected survival < 72 hours;

• Severe confounding respiratory condition (i.e., chest trauma with paradoxical respiration);

• Known or suspected community-acquired bacterial pneumonia.

• Anticipated concomitant use of any of the following medications during the course of study therapy: valproic acid or divalproex sodium. Anticipated concomitant use of serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin 5-HT1 receptor agonists (triptans), meperidine, or buspirone during the course of linezolid treatment.

• Receipt of a monoamine oxidase inhibitor within 14 days prior to the first dose of study drug or anticipated concomitant use during the course of linezolid therapy.