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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Aug 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

    • 12 Jun 2017 Planned End Date changed from 14 Nov 2017 to 29 Sep 2017.
    • 12 Jun 2017 Planned primary completion date changed from 14 Nov 2017 to 29 Sep 2017.
    • 07 Jun 2017 Planned End Date changed from 30 Jun 2017 to 14 Nov 2017.
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