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-1
Phase of Trial: Phase III
Latest Information Update: 29 Sep 2017
At a glance
- Drugs Iclaprim (Primary) ; Vancomycin
- Indications Bacterial infections; Skin and soft tissue infections
- Focus Registrational; Therapeutic Use
- Acronyms REVIVE-1
- Sponsors Motif Bio
- 29 Sep 2017 Submission of a New Drug Application (NDA) for iclaprim for the treatment of ABSSSI is anticipated in the first quarter of 2018, according to a Motif Bio media release.
- 09 Aug 2017 According to a Motif Bio media release,successful results from the two REVIVE trials are expected to satisfy both US FDA and EMA requirements for regulatory submission for intravenous iclaprim in the treatment of ABSSSI. NDA Submission is anticipated in the first half of 2018.
- 22 Jun 2017 According to a Motif Bio media release, data from this trial will be presented during the formal Symposia session at IDWeek 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History