Nosocomial Pneumonia | Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)
Nosocomial Pneumonia research study
What is the primary objective of this study?
This is a phase 3, multicenter, prospective, randomized study of intravenous (IV) ceftolozane/tazobactam vs. IV meropenem in the treatment of adult participants with either ventilator-associated bacterial pneumonia (VABP) or ventilated hospital-acquired bacterial pneumonia (HABP).
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:ceftolozane/tazobactamCeftolozane/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:MeropenemMeropenem is a broad spectrum injectable antibiotic widely used to treat serious infections such as ventilator-associated bacterial pneumonia and hospital-acquired bacterial pneumonia.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Ceftolozane/tazobactamceftolozane/tazobactam IV 3000 mg (comprising 2000 mg ceftolozane and 1000 mg tazobactam) every 8 hours for 8-14 days, or 14 days for Pseudomonas aeruginosa.
meropenemmeropenem IV 1000 mg every 8 hours for 8-14 days, or 14 for Pseudomonas aeruginosa
Active, not recruiting
Start Date: September 23, 2014
Completed Date: June 19, 2018
Phase: Phase 3
Primary Outcome: All Cause Mortality
Secondary Outcome: Clinical response rates at the TOC visit (ceftolozane/tazobactam versus meropenem) in the subset of subjects who had P. aeruginosa from the baseline lower respiratory tract culture
Study sponsors, principal investigator, and references
Principal Investigator: Medical Director
Lead Sponsor: Cubist Pharmaceuticals LLC
Xiao AJ, Miller BW, Huntington JA, Nicolau DP. Ceftolozane/tazobactam pharmacokinetic/pharmacodynamic-derived dose justification for phase 3 studies in patients with nosocomial pneumonia. J Clin Pharmacol. 2016 Jan;56(1):56-66. doi: 10.1002/jcph.566. Epub 2015 Aug 25.