Phase III, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Study of AB103 as Compared to Placebo in Patients with Necrotizing Soft Tissue Infections (NSTI)

Principal Investigator: Bellal Joseph, MD                 

Funding Source: Atox Bio Ltd.

Start Date: August 2016 – September 2019

Enrolling: 290 patients

More Information: https://clinicaltrials.gov/ct2/show/NCT02469857

NSTI are rapidly progressing infections with significant local and systemic manifestations. They represent the most severe types of infections involving the skin, skin structures, and soft tissue. NSTI is a rare disease, with an estimated prevalence of 4.5 cases per 100,000 individuals in Europe and 6.8 cases per 100,000 in the US. Risk factors appear to be diabetes, obesity, intravenous drug use, peripheral vascular disease, and immunosuppression. However, a large proportion of NSTI patients have no predisposition for their infection. The current therapy includes multiple surgical debridements performed during the first 7-14 days of the patient’s hospital stay, along with broad spectrum antibiotics and critical care support. To date, no drug products have been approved for treatment of NSTI. AB103 is being developed for the treatment of NSTI in conjunction with standard care including surgical debridement, antibiotic therapy, and supportive care.

Purpose: the purpose of this study is to determine if AB103 is effective, in conjunction with the standard treatment, at treating patients with NSTI when compared to patients treated with placebo and standard treatment.

For questions about this study, please contact Andrea Seach at 520-626-2876 or aseach@surgery.arizona.edu.