Non‑inferiority, adaptive, double‑blind trial of short‑course versus standard 14‑day caspofungin acetate therapy in adults with uncomplicated candidemia (CanTEN)

The primary objective is to assess whether shorter treatment courses of caspofungin are non-inferior to the standard 14‑day regimen after documented clearance of candidemia, thereby determining if reduced therapy duration can maintain clinical effectiveness. Secondary objectives include:

• Comparison of time to recurrence (relapse or new invasive candidiasis) among 7‑, 10‑, and 14‑day groups;
• Evaluation of global cure rates between treatment arms;
• Assessment of all-cause mortality across groups;
• Assessment of candidemia-attributable mortality;
• Analysis of healthcare resource utilization;
• Comparison of safety of caspofungin treatment;
• Comparison of patient-reported outcomes.

The trial enrolled adult patients (≥18 years) of both sexes, including individuals classified as vulnerable, who had documented Candidemia and were receiving caspofungin therapy; the sponsor did not provide information on the total number of participants, specific age range, or lifestyle characteristics of the enrolled cohort.

The CanTEN trial is a multicenter, randomized, double‑blind, placebo‑controlled, adaptive, non‑inferiority study evaluating a shortened 7‑day course of caspofungin infusion (70 mg) versus continuation of standard 14‑day therapy in patients with uncomplicated candidemia. After a screening visit confirming eligibility and obtaining written informed consent, participants are randomized on Day 1 to receive either caspofungin or an identical‑appearing placebo infusion (1000 ml saline or sodium lactate) administered daily for seven days. Study visits occur on Day 1 (randomization), Day 7 (end of study treatment) and Day 37 (30 days after the last dose) to assess primary and secondary endpoints, including recurrence of infection, clinical and mycological cure, mortality, resource utilization, adverse events, and patient‑reported outcomes. The total duration of individual participation is approximately six weeks, encompassing screening, treatment, and follow‑up. Early termination may occur if a participant experiences a serious adverse event related to the investigational product, fails to meet protocol compliance requirements, withdraws consent, or dies before the final assessment.

The investigational product is caspofungin acetate, supplied for intravenous infusion at a dose of 70 mg per administration. The infusion is delivered through the intravenous route and is administered according to the study dosing schedule, which aligns with the treatment duration defined in the protocol. Compliance with the infusion schedule is monitored by recording infusion start and end times in the electronic case report form.

One placebo comparator consists of sodium lactate solution for infusion. Each dose contains 1000 ml of sodium lactate and is administered intravenously. The infusion is given on the same schedule as the investigational product to maintain blinding, and infusion records are used to verify adherence.

The second placebo comparator is isotonic saline solution for infusion. Each dose comprises 1000 ml of saline, administered intravenously in parallel with the active treatment schedule. Administration times are documented to ensure protocol compliance and to support the double‑blind design of the trial.

Efficacy will be evaluated using the predefined primary and secondary endpoints. The rate of recurrent candidemia and/or other proven invasive candidiasis will be measured at 30 days after the end of study treatment (Day 37). Secondary efficacy parameters include the time from randomization to recurrent infection, clinical cure, radiological cure, and mycological eradication assessed at the end of study treatment (Day 7) and again at Day 37, as well as all‑cause mortality and mortality attributable to candidemia at Day 37.

Assessments will be performed according to the study schedule: baseline evaluations on Day 1, efficacy evaluations on Day 7, and follow‑up assessments on Day 37. Clinical and radiological status will be documented by investigators using standard case report forms, while mycological status will be confirmed through laboratory cultures. Patient‑reported outcomes will be collected using the EQ‑5D‑5L health‑related quality of life instrument and the WHODAS 2.0 physical functioning questionnaire on Day 1 and Day 37.