The Phase 3 trial, also known as the ACCUTE trial (Reltecimod Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections), is designed as a single pivotal study to assess the efficacy and safety of Reltecimod versus placebo in patients with NSTI. The study is planned to recruit 290 patients, utilizing a 1:1 randomization schema, from approximately 60 investigative sites in the US. It will be evaluating the clinical composite endpoint that includes elements of both the local and systemic manifestations of NSTI.
Key secondary endpoints will also be evaluated.
- Secondary endpoints to support clinical outcomes
- Complete and/or partial recovery from AKI (based on Day 28 evaluation)
- Days in ICU and on ventilator
- Time-to-resolution of mSOFA score to ≤ 1
- 30 day hospital readmission rate
- 3 month survival and AKI persistence
Recruitment in the ACCUTE study has been completed. Atox Bio expects to present the results of this study at a medical meeting in the first half of 2020.
For more information, please go to https://clinicaltrials.gov/ct2/show/NCT02469857?term=atox+bio&rank=1