This study will examine the safety and efficacy of a novel antifungal compound, T2307, in a Phase II dose-escalation cohort design, international clinical trial of patients with candidemia due to C. auris and other antifungal-resistant (AFR) Candida species. This multi-center, international trial will be conducted by a carefully selected network of sites, defined by the PI as being characterized as having experience in studying invasive candidiasis, sufficient institutional support, ability to identify Candida to species level in a timely manner using automated technology, and demonstrate sufficient incidence of clinically relevant infections due to target organisms (C. auris and other AFR Candida) to successfully conduct the trial. Sites will be determined in a real-time manner, as emerging trends in incidence and prevalence are reviewed by our consultants and leading public health officials. Underrepresented populations and highly affected populations will be afforded careful attention to encourage inclusion. We will design a Phase II dose-finding clinical trial that will seamlessly evolve into a randomized Phase III trial. We will identify participating sites, determine feasibility, develop a clinical specimen repository, develop SOPs, provide for human subject protections, develop a database, source documents and electronic case report forms, develop monitoring plans, training materials, determine eligibility and exclusion criteria. We will establish a Data Safety Monitoring Board (DSMB) and Data Review Committee (DRC) with defined roles to review safety procedures, to confirm outcomes and validate dose progression and ultimately allow the safe transition to the Phase III design.
Candida auris and other antifungal resistant (AFR) Candida species are emerging globally as a serious threat to health and wellbeing, particularly to those in the healthcare setting. The mortality associated with C auris and other AFR Candida species is high across all populations, and a new therapeutic option could potentially benefit individuals suffering from these infections in a variety of settings worldwide. To address this critical issue, we propose a multicenter, international prospective clinical trial to evaluate a novel antifungal agent (T2307) which demonstrates superb in vitro activity versus Candida species, including C auris and other AFR strains, among subjects with candidemia.
