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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 October 2017 by Cubist Pharmaceuticals LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02070757
First Posted: February 25, 2014
Last Update Posted: October 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
  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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Hide Study Locations
Locations
United States, California
Call for Information (Investigational Site 5516) Recruiting
Fresno, California, United States, 93701
Call for Information (Investigational Site 5521) Recruiting
Sacramento, California, United States, 95817
United States, Connecticut
Call for Information (Investigational Site 5530) Recruiting
New Haven, Connecticut, United States, 06511
United States, Georgia
Call for Information (Investigational Site 5551) Recruiting
Decatur, Georgia, United States, 30033
United States, Illinois
Call for Information (Investigational Site 5524) Recruiting
Chicago, Illinois, United States, 60611
United States, Louisiana
Call for Information (Investigational Site 5546) Recruiting
Shreveport, Louisiana, United States, 71103
United States, Missouri
Call for Information (Investigational Site 5525) Recruiting
Columbia, Missouri, United States, 65212
United States, Nebraska
Call for Information (Investigational Site 5520) Recruiting
Omaha, Nebraska, United States, 68131
United States, Nevada
Call for Information (Investigational Site 5523) Recruiting
Las Vegas, Nevada, United States, 89109
United States, New York
Call for Information (Investigational Site 5549) Recruiting
New York, New York, United States, 10065
Call for Information (Investigational Site 5507) Recruiting
The Bronx, New York, United States, 10467-2490
United States, Ohio
Call for Information (Investigational Site 5508) Recruiting
Lima, Ohio, United States, 45801
Australia
Merck Sharp & Dohme Recruiting
North Ryde, Australia
Contact: Australian Medical Information Centre    61 2 8988 8428      
Belgium
MSD Belgium BVBA/SPRL Recruiting
Brussels, Belgium
Contact: Marc Denayer    32 2 776 60 28      
Brazil
MSD Brasil Recruiting
Sao Paulo, Brazil
Contact: MSD Online    0800 012 22 32      
Colombia
MDS Colombia SAS Recruiting
Bogota, Colombia
Contact: Francesca Carvajal    57 1219109011090      
Croatia
Merck Sharp & Dohme d.o.o Recruiting
Zagreb, Croatia
Contact: Andina Hrabar    385 14878400      
Czechia
MSD SRO Czech Recruiting
Prague, Czechia, Prague 6
Contact: Thomas Johansson    420 233 010 111      
Estonia
Merck Sharp & Dohme OU Recruiting
Tallinn, Estonia
Contact: Katrin Moeschlin    +46 (0) 8ý578ý135 00      
France
MSD France Recruiting
Paris, France
Contact: Dominique Blazy    33 147548990      
Georgia
Merck Sharp & Dohme IDEA, Inc. Recruiting
Tbilisi, Georgia
Contact: Eran Gefen    38 (044) 393 74 80      
Germany
MSD Sharp & Dohme GmbH Recruiting
Haar, Germany
Contact: German Medical Information Center    49 800 673 673 673      
Guatemala
MSD CARD Recruiting
Guatemala, Guatemala
Contact: Soraya Cedraro    507-282-7200      
Hungary
MSD Pharma Hungary Kft. Recruiting
Budapest, Hungary
Contact: Szabolcs Barotfi    36 1 888 5300      
Ireland
MSD Ireland (Human Health) Ltd. Recruiting
Dublin, Ireland
Contact: Colm Galligan    353 12998700      
Israel
Merck Sharp & Dohme Co. Ltd. Recruiting
Hod Hasharon, Israel
Contact: Gally Teper    972-9-9533310      
Italy
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Patrizia Nardini    39 06 361911      
Latvia
Merck Sharp & Dohme Latvija SIA Recruiting
Riga, Latvia
Contact: Katrin Moeschlin    +46 (0) 8ý578ý135 00      
Lebanon
MSD Idea, Inc. - LB BR Recruiting
Beirut, Lebanon
Contact: Yehia Nabil    97144269184      
New Zealand
Merck Sharp & Dohme (New Zealand) Ltd., Recruiting
Wellington, New Zealand
Contact: Australian Medical Information Centre    61 2 8988 8428      
Philippines
Merck Sharp & Dohme (I.A.) Corporation Recruiting
Makati, Philippines
Contact: Cesar Recto    632 784 9500      
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Tatiana Serebriakova    74959167100, EXT.366      
Serbia
Merck Sharp & Dohme Recruiting
Belgrade, Serbia
Contact: Eran Gefen    38 (044) 393 74 80      
South Africa
MSD (Pty) LTD South Africa Recruiting
Midrand, South Africa
Contact: Khanyi Mzolo    27 11 655 3140      
Spain
Merck Sharp and Dohme de Espana S.A. Recruiting
Madrid, Spain
Contact: Joaquin Mateos Chacon    (0034) 913210600      
Ukraine
MSD Ukraine LLC Recruiting
Kiev, Ukraine
Contact: Eran Gefen    38 (044) 393 74 80      
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Mark Toms    +44 (0) 1992 452475      
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: October 20, 2017
Last Verified: October 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:
Tazobactam
Ceftolozane, tazobactam drug combination
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Meropenem
Thienamycins
Penicillanic Acid
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents