A Phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of intravenous iclaprim versus vancomycin in the treatment of acute bacterial skin and skin structure infections suspected or confirmed to be due to Gram-positive pathogens. REVIVE-2
Phase of Trial: Phase III
Latest Information Update: 10 Oct 2017
At a glance
- Drugs Iclaprim (Primary) ; Vancomycin
- Indications Bacterial infections; Skin and soft tissue infections
- Focus Registrational; Therapeutic Use
- Acronyms REVIVE-2
- Sponsors Motif Bio
- 04 Oct 2017 Top-line data presented in a Motif Bio Media Release.
- 04 Oct 2017 Primary endpoint has been met. (20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT), according to a Motif Bio media release.
- 29 Sep 2017 Submission of a New Drug Application (NDA) for iclaprim for the treatment of ABSSSI is anticipated in the first first quarter of 2018, according to a Motif Bio media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History