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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 22, 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
  Purpose
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).

Condition Intervention Phase
Nosocomial Pneumonia Drug: ceftolozane/tazobactam Drug: Meropenem Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals LLC:

Primary Outcome Measures:
  • All Cause Mortality [ Time Frame: Day 28 ]
    Intent-to-Treat (ITT) population


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 726
Actual Study Start Date: September 23, 2014
Estimated Study Completion Date: June 19, 2018
Estimated Primary Completion Date: May 28, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Active Comparator: meropenem
meropenem IV 1000 mg every 8 hours for 8-14 days, or 14 for Pseudomonas aeruginosa
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070757


Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 38 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT02070757     History of Changes
Other Study ID Numbers: 7625A-008
CXA-NP-11-04 ( Other Identifier: Cubist Protocol Number )
163338 ( Registry Identifier: JAPIC-CTI )
First Submitted: February 19, 2014
First Posted: February 25, 2014
Last Update Posted: November 22, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cubist Pharmaceuticals LLC:
Ventilator-associated bacterial pneumonia
Hospital-acquired bacterial pneumonia
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Ventilator-Induced Lung Injury
Lung Injury

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Meropenem
Thienamycins
Tazobactam
Penicillanic Acid
Cephalosporins
Ceftolozane, tazobactam drug combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents