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

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ClinicalTrials.gov Identifier: NCT02493764
Recruitment Status : Recruiting
First Posted : July 9, 2015
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bacterial Pneumonia Drug: Imipenem Drug: Relebactam Drug: Cilastatin Drug: Piperacillin Drug: Tazobactam Drug: Linezolid Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 24, 2015
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
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.
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: Linezolid
Linezolid 600 mg administered open-label by IV every 12 hours for up to 14 days

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.
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




Primary Outcome Measures :
  1. Percentage of participants surviving at Day 28 [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. 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) ]


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

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

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): NCT02493764


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

  Hide Study Locations
Locations
United States, California
Call for Information (Investigational Site 0546) Recruiting
Fresno, California, United States, 93701
Call for Information (Investigational Site 0512) Recruiting
Sacramento, California, United States, 95817
United States, Florida
Call for Information (Investigational Site 0504) Recruiting
Miami, Florida, United States, 33136
United States, Illinois
Call for Information (Investigational Site 0518) Recruiting
Chicago, Illinois, United States, 60611
United States, Iowa
Call for Information (Investigational Site 0522) Recruiting
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Call for Information (Investigational Site 0524) Recruiting
Boston, Massachusetts, United States, 02115
Call for Information (Investigational Site 0549) Recruiting
Burlington, Massachusetts, United States, 01805
United States, New York
Call for Information (Investigational Site 0537) Recruiting
New York, New York, United States, 10021
United States, Ohio
Call for Information (Investigational Site 0529) Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Call for Information (Investigational Site 0525) Recruiting
Philadelphia, Pennsylvania, United States, 19141
Argentina
Merck Sharp & Dohme Recruiting
Buenos Aires, Argentina
Contact: Claudia Beatriz Trillo    54 11 6090 7336      
Australia
Merck Sharp & Dohme Recruiting
North Ryde, Australia
Contact: Australian Medical Information Centre    61 2 8988 8428      
Brazil
MSD Brasil Recruiting
Sao Paulo, Brazil
Contact: MSD Online    0800 012 22 32      
Bulgaria
Merck Sharp & Dohme Bulgaria EOOD Recruiting
Sofia, Bulgaria
Contact: Florina Prundaru    40212333530      
Canada, Quebec
Merck Canada Recruiting
Kirkland, Quebec, Canada, H9H 4M7
Contact: Medical Information Centre Centre d'information medicale Merck Canada Inc.    514-428-8600 / 1-800-567-2594      
Colombia
MDS Colombia SAS Recruiting
Bogota, Colombia
Contact: Liliana Ferro    57 12191093      
Croatia
Merck Sharp & Dohme d.o.o Recruiting
Zagreb, Croatia
Contact: Szabolcs Barotfi    36 1 888 5300      
Estonia
Merck Sharp & Dohme OU Recruiting
Tallinn, Estonia
Contact: Katrin Moeschlin    460857813500      
France
MSD France Recruiting
Paris, France
Contact: Valerie Bouchara    33 180464417      
Guatemala
MSD CARD Recruiting
Guatemala, Guatemala
Contact: Edgar R Hernandez    502 24979595      
Italy
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Paola Chiaretta Fattore    39 0636191739      
Japan
MSD K.K. Recruiting
Chiyoda-Ku, Tokyo, Japan, 102-8667
Contact: Japan Call Center    81-3-6272-1957      
Korea, Republic of
MSD Korea LTD Recruiting
Seoul, Korea, Republic of, 4130
Contact: TaeYoun Jo    8223312313      
Latvia
Merck Sharp & Dohme Latvija SIA Recruiting
Riga, Latvia
Contact: Katrin Moeschlin    460857813500      
Lithuania
UAB "Merck Sharp & Dohme" Recruiting
Vilnius, Lithuania
Contact: Katrin Moeschlin    460857813500      
Mexico
MSD Recruiting
Mexico City, Mexico
Contact: Alexandra Barajas    52 5554819650      
Norway
MSD Norge A/S Recruiting
Drammen, Norway
Contact: Katrin Moeschlin    46857813545      
Peru
Merck Sharp & Dohme, Peru S.R.L. Recruiting
Lima, Peru
Contact: Rodolfo Lozano    5114115910      
Philippines
Merck Sharp & Dohme (I.A.) Corporation Recruiting
Makati, Philippines
Contact: Georgina Arnold    61289888212      
Portugal
Merck Sharp & Dohme Lda. Recruiting
Paco D'arcos, Portugal
Contact: Lourdes Lopez-Bravo    (0034) 913210654      
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: Szabolcs Barotfi    36 1 888 5300      
Spain
Merck Sharp and Dohme de Espana S.A. Recruiting
Madrid, Spain
Contact: Lourdes Lopez-Bravo    (0034) 913210654      
Turkey
Merck Sharp & Dohme Ilaclari Ltd. Sti Recruiting
Istanbul, Turkey
Contact: Betul Erdogan    2123361232      
Ukraine
MSD Ukraine LLC Recruiting
Kiev, Ukraine
Contact: Serhiy Mykhaylov    38 050 3107198      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02493764     History of Changes
Other Study ID Numbers: 7655A-014
2015-000246-34 ( EudraCT Number )
163240 ( Registry Identifier: JAPIC-CTI )
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Linezolid
Tazobactam
Penicillanic Acid
Piperacillin
Imipenem
Piperacillin, tazobactam drug combination
MK-7655
Cilastatin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors
Protease Inhibitors