Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study of AB103 as Compared to Placebo in Patients With Necrotizing Soft Tissue Infections. ACCUTE (AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections)
Phase of Trial: Phase III
Latest Information Update: 13 Oct 2017
At a glance
- Drugs Reltecimod (Primary)
- Indications Bacterial infections; Soft tissue infections
- Focus Therapeutic Use
- Acronyms ACCUTE
- Sponsors Atox Bio
- 23 May 2017 According to an Atox Bio media release, this trial will continue as planned without modification based on the successful completion of pre-specified futility analysis. The recommendation was made by the independent Data Monitoring Committee (DMC) after evaluating efficacy and safety data from the first 102 patients enrolled.
- 21 Nov 2016 Planned End Date changed from 1 Jan 2018 to 1 Mar 2019.
- 21 Nov 2016 Planned primary completion date changed from 1 Sep 2017 to 1 Dec 2018.