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Clinical trials for Relebactam

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    6 result(s) found for: Relebactam. Displaying page 1 of 1.
    EudraCT Number: 2015-000246-34 Sponsor Protocol Number: 7655A-014 Start Date*: 2015-09-28
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full 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/T...
    Medical condition: Treatment for hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) EE (Completed) LV (Completed) BG (Completed) PT (Completed) LT (Completed) FR (Completed) ES (Completed) HR (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-000338-20 Sponsor Protocol Number: MK-7655A-021 Start Date*: 2019-06-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Tha...
    Medical condition: Treatment of bacterial infections in pediatric populations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) PL (Completed) Outside EU/EEA ES (Completed) BG (Completed) GR (Completed) NO (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004328-43 Sponsor Protocol Number: MK-7655A-020 Start Date*: 2017-09-19
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Susp...
    Medical condition: Treatment of bacterial infections in pediatric populations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed) PL (Completed) Outside EU/EEA GB (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2018-003202-82 Sponsor Protocol Number: MK7655A-016 Start Date*: 2019-07-09
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Pip...
    Medical condition: Hospital-Acquired Bacterial Pneumonia / Ventilator-Associated Bacterial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10004051 Bacterial pneumonia, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2015-000066-62 Sponsor Protocol Number: 7655A-013 Start Date*: 2015-08-04
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Estimate the Efficacy and Safety of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium + Im...
    Medical condition: imipenem-resistant bacterial infections, including hospital-associated or ventilator acquired pneumonia (HABP/VABP), complicated intra-abdominal infection (cIAI) or complicated urinary tract infect...
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) EE (Completed) LV (Completed) RO (Completed) LT (Completed) GR (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-001396-16 Sponsor Protocol Number: OP0595-6 Start Date*: 2023-03-29
    Sponsor Name:Meiji Seika Pharma Co., Ltd.
    Full Title: A Phase 3, Multi-Center, Randomized, Single-Blind Study to Assess the Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy in Adults With Complicated Ur...
    Medical condition: Complicated urinary tract infection (cUTI), acute uncomplicated pyelonephritis (AP), hospital acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and complicated ...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004862 10080628 Complicated urinary tract infection LLT
    20.1 100000004862 10079985 Uncomplicated pyelonephritis LLT
    21.1 100000004862 10081414 Ventilator associated bacterial pneumonia LLT
    20.1 100000004862 10079983 Complicated intra-abdominal infection LLT
    21.1 100000004862 10081416 Hospital acquired bacterial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) SK (Trial now transitioned) GR (Trial now transitioned) LV (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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