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

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Apr 2018

At a glance

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

    • 24 Apr 2018 Results presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases
    • 22 Apr 2018 Results were presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2018 meeting, as reported in a Merck & Co media release.
    • 22 Apr 2018 Based on the results of this trial, the company plans to submit a New Drug Application to the U.S. Food and Drug Administration seeking regulatory approval of a fixed-dose combination of imipenem/cilastatin and relebactam.
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