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
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
- 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.