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

ID: NCT02070757
Status: Recruiting
Phase: Phase 3
Start Date: September 23, 2014
First Submitted: February 19, 2014
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: Belgium, Brazil, Canada, 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
Conditions: Nosocomial Pneumonia
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Study Description

Brief Summary

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).

Detailed Description

Condition or disease Intervention/treatment Phase

Nosocomial Pneumonia

Drug: ceftolozane/tazobactam
Other Names
Drug: Meropenem
Other Names
Merofit Monan Meronem Merrem
Phase 3

Tracking Information

First Submitted DateFebruary 19, 2014
Last Update Posted DateFebruary 22, 2018
Actual Start DateSeptember 23, 2014
Anticipated Completion DateJune 19, 2018
Actual Primary Completion DateMay 28, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • All Cause Mortality [Time Frame: Day 28]

    Intent-to-Treat (ITT) population

Original Primary Outcome Measures

Not Available

Current 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]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleSafety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)
Official TitleA 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
Brief Summary

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).

Detailed Description

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
726
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Nosocomial Pneumonia
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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.

Other Names
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
Study Groups/Cohorts
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.

meropenem
meropenem IV 1000 mg every 8 hours for 8-14 days, or 14 for Pseudomonas aeruginosa

Study Arms
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.

Arm Intervention/Treatment
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
Active Comparator meropenem
meropenem IV 1000 mg every 8 hours for 8-14 days, or 14 for Pseudomonas aeruginosa
Drug : Meropenem

Recruitment Information

Recruitment Status:Recruiting
Enrollment726
Completion DateJune 19, 2018
Eligibility 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Belgium
Brazil
Canada
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
Australia
Austria
Czech Republic
Greece
Japan
Korea, Republic of
Portugal
Slovakia
Taiwan

Administrative Information

NCT Number:NCT02070757
Other Study ID Numbers
7625A-008
CXA-NP-11-04
163338
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Study Director
Medical Director
Merck Sharp & Dohme Corp.