Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial

CanTEN is a multicenter, randomized, double‐blind, placebo‐controlled, adaptive,non‐inferiority phase 4 trial investigating a shortened treatment duration in patientswith uncomplicated candidemia. Current guidelines recommend a 14‐day treatment afterdocumented clearance of candidemia. The traditional 14‐day treatment duration foruncomplicated candidemia is not sufficiently evidence‐based. In a variety of bacterialinfections, shorter treatment has been proven safe and efficacious, thus reducingresistance development, toxicity, and costs.This study aims to demonstrate the non‐inferiority of 10 days (Group B) of treatmentcompared to 14 days (Group A) in patients with a controlled source of candidemia. Oncethe primary endpoint have been assessed in 50% of the participants, an unblinded interimanalysis will be conducted. If non‐inferiority can be demonstrated, Group C will beinitiated with a 7‐day treatment duration.The primary endpoint is the rate of recurrent candidemia and/or other proven invasivecandidiasis at 30 days after end of study treatment (Day 37). Secondary endpoints includethe time from randomization to recurrent candidemia and/or other proven invasivecandidiasis, clinical cure, radiological cure and mycological eradication at the end ofstudy treatment (Day 7) and at 30 days after end of study treatment (Day 37). Inaddition, all‐cause mortality and mortality attributable to candidemia and/or otherproven invasive candidiasis will be measured at 30 days after end of study treatment (Day37) . Additional secondary endpoints include candidemia‐attributable healthcare resourcesuse 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 patientreported outcome measures (PROMs; EQ‐5D‐5L and WHODAS 2.0) on Day 1 and Day 37. As anexploratory endpoint, the study will examine the impact of age, sex, relevantcomorbidities, SOFA and qSOFA score, use of vasopressors and Candida species onrecurrence of candidemia.