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: 05 Dec 2017

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

    • 03 Oct 2017 This trial has been completed in Lithuania, according to European Clinical Trials Database record.
    • 27 Sep 2017 Status changed from active, no longer recruiting to completed.
    • 01 Sep 2017 Status changed from recruiting to active, no longer recruiting.
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