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:
Participant gender:
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%.