Trials / Completed
CompletedNCT02070757
Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 726 (actual)
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ceftolozane/tazobactam | 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. |
| DRUG | Meropenem | Meropenem is a broad spectrum injectable antibiotic widely used to treat serious infections such as ventilator-associated bacterial pneumonia and hospital-acquired bacterial pneumonia. |
Timeline
- Start date
- 2014-09-02
- Primary completion
- 2018-05-15
- Completion
- 2018-06-06
- First posted
- 2014-02-25
- Last updated
- 2020-05-05
- Results posted
- 2019-05-31
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02070757. Inclusion in this directory is not an endorsement.