We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
  Purpose
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 Intervention Phase
Bacterial Pneumonia Drug: Imipenem Drug: Relebactam Drug: Cilastatin Drug: Piperacillin Drug: Tazobactam Drug: Linezolid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 536
Actual Study Start Date: November 24, 2015
Estimated Study Completion Date: May 31, 2019
Estimated Primary Completion Date: May 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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

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
  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): NCT02493764


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

  Hide Study Locations
Locations
United States, Alabama
Call for Information (Investigational Site 0514) Recruiting
Birmingham, Alabama, United States, 35249
United States, California
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
United States, Michigan
Call for Information (Investigational Site 0500) Recruiting
Detroit, Michigan, United States, 48202
United States, Nevada
Call for Information (Investigational Site 0506) Recruiting
Las Vegas, Nevada, United States, 89109
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 (Argentina) Inc. Recruiting
Buenos Aires, Argentina
Contact: Alfredo Wilkinson    54 11 4796 8200      
Brazil
MSD Brasil Recruiting
Sao Paulo, Brazil
Contact: MSD Online    0800 012 22 32      
Bulgaria
Merck Sharp & Dohme Bulgaria EOOD Recruiting
Sofia, Bulgaria
Contact: Eran Gefen    38 (044) 393 74 80      
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: Francesca Carvajal    57 1219109011090      
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      
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      
Italy
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Patrizia Nardini    39 06 361911      
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: Jongho Ahn    82-2-331-2000 2015      
Latvia
Merck Sharp & Dohme Latvija SIA Recruiting
Riga, Latvia
Contact: Katrin Moeschlin    +46 (0) 8ý578ý135 00      
Lithuania
UAB "Merck Sharp & Dohme" Recruiting
Vilnius, Lithuania
Contact: Katrin Moeschlin    +46 (0) 8ý578ý135 00      
Mexico
MSD Recruiting
Mexico City, Mexico
Contact: Juan Marques    52 55254819608      
Norway
MSD Norge A/S Recruiting
Drammen, Norway
Contact: Tony Johansson    47 32 20 75 20      
Philippines
Merck Sharp & Dohme (I.A.) Corporation Recruiting
Makati, Philippines
Contact: Cesar Recto    632 784 9500      
Portugal
Merck Sharp & Dohme Lda. Recruiting
Paco Darcos, Portugal
Contact: Ana Maria Nogueira    351-21-4465890      
Romania
Merck Sharp & Dohme Romania SRL Recruiting
Bucharest, Romania
Contact: Simona Olaru    38 (044) 393 74 80      
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Tatiana Serebriakova    74959167100, EXT.366      
Turkey
Merck Sharp & Dohme Ilaclari Ltd. Sti Recruiting
Istanbul, Turkey
Contact: Alev Eren    90 212 336 12 63      
Ukraine
MSD Ukraine LLC Recruiting
Kiev, Ukraine
Contact: Eran Gefen    38 (044) 393 74 80      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

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 Submitted: July 7, 2015
First Posted: July 9, 2015
Last Update Posted: November 2, 2017
Last Verified: October 2017

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