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Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014) (RESTORE-IMI 2)

This study is currently recruiting participants.
Verified October 2017 by Merck Sharp & Dohme Corp.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02493764
First Posted: July 9, 2015
Last Update Posted: November 2, 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):
Merck Sharp & Dohme Corp.
July 7, 2015
July 9, 2015
November 2, 2017
November 24, 2015
May 31, 2019   (Final data collection date for primary outcome measure)
Percentage of participants surviving at Day 28 [ Time Frame: Day 28 ]
Same as current
Complete list of historical versions of study NCT02493764 on ClinicalTrials.gov Archive Site
Percentage of participants with a favorable clinical response at early follow up visit [ Time Frame: Up to 16 days after end of therapy (up to Day 30) ]
Same as current
Not Provided
Not Provided
 
Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)
A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
This study aims to compare treatment with imipenem/relebactam/cilastatin (IMI/REL) as a fixed-dose combination (FDC) with piperacillin/tazobactam (PIP/TAZ) FDC in participants with hospital-acquired and ventilator-associated bacterial pneumonia. The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ in the incidence rate of all-cause mortality.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Bacterial Pneumonia
  • Drug: Imipenem
    Imipenem 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
  • Drug: Relebactam
    Relebactam 250 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
  • Drug: Cilastatin
    Cilastatin 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
  • Drug: Piperacillin
    Piperacillin 4000 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
  • Drug: Tazobactam
    Tazobactam 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
  • Drug: Linezolid
    Linezolid 600 mg administered open-label by IV every 12 hours for up to 14 days
  • Experimental: IMI/REL
    Imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered intravenously (IV) every 6 hours for a minimum of 7 days, up to 14 days. At study entry open label linezolid 600 mg will also be administered by IV every 12 hours for up to 14 days.
    Interventions:
    • Drug: Imipenem
    • Drug: Relebactam
    • Drug: Cilastatin
    • Drug: Linezolid
  • Active Comparator: PIP/TAZ
    Piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At study entry open label linezolid 600 mg will also be administered by IV every 12 hours for up to 14 days.
    Interventions:
    • Drug: Piperacillin
    • Drug: Tazobactam
    • Drug: Linezolid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
536
May 31, 2019
May 31, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Requires treatment with IV antibiotic therapy for hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP)
  • Fulfills clinical and radiographic criteria, with onset of criteria occurring after more than 48 hour of hospitalization or within 7 days after discharge from a hospital (for HABP); or at least 48 hours after mechanical ventilation (for VABP)
  • Has an adequate baseline lower respiratory tract specimen obtained for Gram stain and culture
  • Has an infection known or thought to be caused by microorganisms susceptible to the IV study therapy
  • Agrees to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided to the Central Microbiology Reference Laboratory for study-related microbiological testing, long term storage, and other future testing
  • Is not of reproductive potential; or if of reproductive potential agrees to avoid impregnating a partner or avoid becoming pregnant, by practicing abstinence or using acceptable contraception

Exclusion Criteria:

  • Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only
  • Has confirmed or suspected community-acquired bacterial pneumonia (CABP)
  • Has confirmed or suspected pneumonia of viral, fungal or parasitic origin
  • Has HABP/VABP caused by an obstructive process, including lung cancer or other known obstruction
  • Has a carcinoid tumor or carcinoid syndrome
  • Has active immunosuppression defined as either receiving immunosuppressive medications or having a medical condition associated with immunodeficiency
  • Is expected to survive for less than 72 hours
  • Has a concurrent condition or infection that would preclude evaluation of therapeutic response
  • Has received effective antibacterial drug therapy for the index infection of HABP/VABP for more than 24 hours continuously, during the previous 72 hours
  • Has a history of serious allergy, hypersensitivity or a serious reaction to any penicillin or beta-lactamase inhibitors
  • Female is pregnant, expecting to conceive, is breastfeeding or plans to breastfeed
  • Has a history of seizure disorder requiring ongoing prior treatment with anti-convulsive therapy within the last 3 years
  • Anticipates treatment with the following: valproic acid or divalproex sodium, serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin receptor antagonists, meperidine, buspirone, concomitant systemic antibacterial agents, antifungal or antiviral therapy for the index infection of HABP/VABP
  • Is currently undergoing hemodialysis or peritoneal dialysis
  • Is currently participating in, has participated in during the previous 30 days, or anticipates to participate in any other clinical study involving the administration of experimental medication
  • Has previously participated in this study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Toll Free Number 1-888-577-8839
Argentina,   Brazil,   Bulgaria,   Canada,   Colombia,   Estonia,   France,   Germany,   Guatemala,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Norway,   Philippines,   Portugal,   Romania,   Russian Federation,   Turkey,   Ukraine,   United States
 
 
NCT02493764
7655A-014
2015-000246-34 ( EudraCT Number )
163240 ( Registry Identifier: JAPIC-CTI )
Yes
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2017

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