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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 + Imipenem/Cilastatin in Subjects With Imipenem-Resistant Bacterial Infection

Trial Profile

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 + Imipenem/Cilastatin in Subjects With Imipenem-Resistant Bacterial Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2022

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At a glance

  • Drugs Cilastatin/imipenem/relebactam (Primary) ; Colistimethate sodium; Imipenem/cilastatin
  • Indications Bacterial infections; Gram-negative infections; Intra-abdominal infections; Nosocomial pneumonia; Urinary tract infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms RESTORE-IMI 1
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 09 Nov 2022 Results assessing the cost effectiveness (model includes data from the RESTORE-IMI-1 trial) of Imipenem/cilastatin/relebactam in gram negative infections in Greece, presented at the 25th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 20 May 2021 A US single payer model with a lifetime horizon comprising a decision-tree depicting initial hospitalization and a Markov model projecting long-term health and economic impact was developed using RESTORE-IMI 1 and US surveillance data, results presented at the 26th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
    • 24 Feb 2020 Results of comparison of treatment outcomes between analysis populations in the RESTORE-IMI 1 Phase 3 trial of Imipenem/Cilastatin/Relebactam Versus Colistin Plus Imipenem/Cilastatin in patients with imipenem-nonsusceptible bacterial infections has been published in the Antimicrobial Agents and Chemotherapy
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