CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 726 enrolled
Drug / intervention
Ceftolozane/tazobactam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02070757
NCT02070757Phase 3Completed
CompareCT.gov

A Prospective, Randomized, Double-Blind, Multicenter, Phase 3 Study to Assess the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam Compared With Meropenem in Adult Patients With Ventilated Nosocomial Pneumonia

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Feb 25, 2014·Updated May 5, 2020

In Brief

A Phase 3 clinical trial evaluating Ceftolozane/tazobactam and Meropenem for Healthcare-Associated Pneumonia and 2 related conditions. Completed, enrolled 726 participants.

Detailed 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%.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthcare-Associated Pneumonia, Ventilator-Associated Pneumonia, Lung Diseases
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2014
Enrollment StartSep 2, 2014
Primary CompletionMay 15, 2018
Study CompletionJun 6, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 12.4 years ago

Interventions

Ceftolozane/tazobactamdrug

Ceftolozane/tazobactam is an antibacterial consisting of a co-formulation of ceftolozane, a novel antipseudomonal cephalosporin and tazobactam, a well-established beta (β)-lactamase inhibitor (BLI) being developed for the treatment of serious bacterial infections.

Meropenemdrug

Meropenem is a broad spectrum injectable antibiotic widely used to treat serious infections such as ventilator-associated bacterial pneumonia and hospital-acquired bacterial pneumonia.