Clinical trials

CanTEN is a multicenter, randomized, double-blind, placebo-controlled, adaptive, non-inferiority phase 4 trial investigating a shortened treatment duration in patients with uncomplicated candidemia. Current guidelines recommend a 14-day treatment after documented clearance of candidemia. The traditional 14-day treatment duration for uncomplicated candidemia is not sufficiently evidence-based. In a variety of bacterial infections, shorter treatment has been proven safe and efficacious, thus reducing resistance development, toxicity, and costs. This study aims to demonstrate the non-inferiority of 10 days (Group B) of treatment compared to 14 days (Group A) in patients with a controlled source of candidemia. Once the primary endpoint have been assessed in 50% of the participants, an unblinded interim analysis will be conducted. If non-inferiority can be demonstrated, Group C will be initiated with a 7-day treatment duration. The primary endpoint is the rate of recurrent candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment (Day 37). Secondary endpoints include the time from randomization to recurrent candidemia and/or other proven invasive candidiasis, clinical cure, radiological cure and mycological eradication at the end of study treatment (Day 7) and at 30 days after end of study treatment (Day 37). In addition, all-cause mortality and mortality attributable to candidemia and/or other proven invasive candidiasis will be measured at 30 days after end of study treatment (Day 37) . Additional secondary endpoints include candidemia-attributable healthcare resources use at 30 days after end of study treatment (Day 37), Caspofungin-related adverse events (AEs) occurring until 30 days after last administration of caspofungin and patient reported outcome measures (PROMs; EQ-5D-5L and WHODAS 2.0) on Day 1 and Day 37. As an exploratory endpoint, the study will examine the impact of age, sex, relevant comorbidities, SOFA and qSOFA score, use of vasopressors and Candida species on recurrence of candidemia.