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

This study is currently recruiting participants.
Verified November 2017 by Cubist Pharmaceuticals LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02070757
First Posted: February 25, 2014
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
February 19, 2014
February 25, 2014
November 20, 2017
September 23, 2014
May 28, 2018   (Final data collection date for primary outcome measure)
All Cause Mortality [ Time Frame: Day 28 ]
Intent-to-Treat (ITT) population
Same as current
Complete list of historical versions of study NCT02070757 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: TOC is 7-14 days after EOT ]
  • Day 28 all-cause mortality rates of participants in the ceftolozane/tazobactam versus meropenem arms in the Microbiological Intent-to-Treat (mITT) population [ Time Frame: Day 28 ]
  • Clinical response rates of ceftolozane/tazobactam versus meropenem in adult participants with ventilated nosocomial pneumonia (VNP) in the Microbiological Intent-to-Treat (mITT) population [ Time Frame: This will be assessed at the Test-of-cure (TOC) visit which is 7 to 14 days after the End of Therapy (EOT) visit ]
  • Clinical response rates of ceftolozane/tazobactam versus meropenem in adult participants with VNP in the Intent-to-Treat (ITT) population [ Time Frame: This will be assessed at the Test-of-cure (TOC) visit which is 7 to 14 days after the End of Therapy (EOT) visit ]
  • Clinical response rates of ceftolozane/tazobactam versus meropenem in adult participants with VNP in the Clinically Evaluable (CE) population [ Time Frame: This will be assessed at the Test-of-cure (TOC) visit which is 7 to 14 days after the End of Therapy (EOT) visit ]
  • Clinical response rates of ceftolozane/tazobactam versus meropenem in adult subjects with VNP. [ Time Frame: This will be assessed at the Test-of-cure (TOC) visit which is 7 to 14 days after the End of Therapy (EOT) visit ]
  • Clinical response rates of ceftolozane/tazobactam versus meropenem in adult subjects with VNP. [ Time Frame: This will be assessed within 24 hours after EOT ]
  • Clinical response rates at the Late Follow-up (LFU) visit for ceftolozane/tazobactam versus meropenem in adult subjects with VNP. [ Time Frame: LFU occurs 28 to 35 days after EOT ]
  • Microbiological response rates of ceftolozane/tazobactam versus meropenem at TOC. [ Time Frame: This will occur at the TOC which is 7-14 days after EOT ]
  • Microbiological response rates of ceftolozane/tazobactam versus meropenem at EOT [ Time Frame: EOT visit occurs within 24 hours after last dose of study drug ]
  • Clinical response rates at the TOC visit (ceftolozane/tazobactam versus meropenem) in the subset of subjects who had P. aeruginosa or Enterobacteriaceae isolated from the baseline lower respiratory tract culture [ Time Frame: TOC is 7-14 days after EOT ]
  • Day 14 all-cause mortality rates of subjects in the ceftolozane/tazobactam versus meropenem arms [ Time Frame: Day 14 ]
  • All-cause mortality in the ceftolozane/tazobactam versus meropenem arms [ Time Frame: All study visits through the LFU visit (28-35 days following the EOT visit) ]
  • Safety will be evaluated in the safety population by presenting summaries of deaths, AEs, laboratory evaluations, vital signs and physical exam in the 2 treatment groups [ Time Frame: All study visits through the LFU visit (28-35 days following the EOT visit) ]
  • Pharmacokinetic parameters, such as maximum concentration achieved (Cmax), total exposure during one dosing interval (AUC0-τ), steady-state volume of distribution (Vss) and Clearance (CLss) [ Time Frame: Day 3 ]
Not Provided
Not Provided
 
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Nosocomial Pneumonia
  • 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.
    Other Names:
    • Merofit
    • Monan
    • Meronem
    • Merrem
  • Experimental: Ceftolozane/tazobactam
    ceftolozane/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.
    Intervention: Drug: ceftolozane/tazobactam
  • Active Comparator: meropenem
    meropenem IV 1000 mg every 8 hours for 8-14 days, or 14 for Pseudomonas aeruginosa
    Intervention: Drug: Meropenem
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
726
June 19, 2018
May 28, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Toll Free Number 1-888-577-8839
Australia,   Belgium,   Brazil,   Colombia,   Croatia,   Czechia,   Estonia,   France,   Georgia,   Germany,   Guatemala,   Hungary,   Ireland,   Israel,   Italy,   Latvia,   Lebanon,   New Zealand,   Philippines,   Russian Federation,   Serbia,   South Africa,   Spain,   Ukraine,   United Kingdom,   United States
Austria,   Canada,   Czech Republic,   Greece,   Japan,   Korea, Republic of,   Portugal,   Slovakia,   Taiwan
 
NCT02070757
7625A-008
CXA-NP-11-04 ( Other Identifier: Cubist Protocol Number )
163338 ( Registry Identifier: JAPIC-CTI )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Cubist Pharmaceuticals LLC
Cubist Pharmaceuticals LLC
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Cubist Pharmaceuticals LLC
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP