A Phase 4 interventional study of Caspofungin only within the study and Caspofungin for 3 days within the study in Candidemia and Invasive Candidiasis, sponsored by Oliver Cornely, MD. Not yet recruiting at 24 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Oliver Cornely, MD · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Group A ist standard in terms of duration of caspofungin treatment. Study treatment is 7 days of caspofungin. The number of days on caspofungin prior to study treatment and during study treatment thus totals 14 after documented clearance of candidemia, as per SmPC label. The single caspofungin dose is as per SmPC label throughout, according to participant's body weight and administered IV. once daily.
Drug: Caspofungin only within the study
Group B is investigational, i.e. off-label in terms of duration of caspofungin treatment. Study treatment is 3 days of caspofungin followed by 4 days of placebo. The number of days on caspofungin prior to study treatment and during study treatment thus totals 10 after documented clearance of candidemia. The single caspofungin dose is as per SmPC label throughout, according to participant's body weight and administered IV once daily.
Drug: Caspofungin for 3 days within the study · Drug: Placebo for 4 days within the study
Group C is investigational, i.e. off-label in terms of duration of caspofungin treatment, as there is no caspofungin administered on study. Study treatment is 7 days of placebo. The number of days on caspofungin prior to study treatment thus totals 7 after documented clearance of candidemia, with no caspofungin administered during study treatment. Group C may only be started depending on the results of the interim analysis.
Drug: Placebo only within the study
Seven days of caspofungin on-study.
Also known as: Cancidas
3 days of caspofungin followed by 4 days of placebo.
Also known as: Cancidas
Zero days of caspofungin on-study.
3 days of caspofungin followed by 4 days of placebo.
Rate of recurrent candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment (Day 37)
Time frame: Day 37 of study (end of the study for the individual participant)
Time from randomization to recurrent candidemia and/or other proven invasive candidiasis
Time frame: From enrolment to Day 37 of study
Clinical cure, radiological cure and mycological eradication at end of study treatment (Day 7)
The outcome is cure "yes/no" as secondary outcome measure. The specifier "clinical", "radiological" and "mycological eradication" is only ancillary information for "cure", each answered with "yes" or "no".
Time frame: Day 7 of study
Clinical cure, radiological cure and mycological eradication at 30 days after end of study treatment (Day 37)
The outcome is cure "yes/no" as secondary outcome measure. The specifier "clinical", "radiological" and "mycological eradication" is only ancillary information for "cure", each answered with "yes" or "no".
Time frame: Day 37 of study
All-cause mortality at 30 days after end of study treatment (Day 37)
Time frame: Day 37 of study
Mortality attributable to candidemia and/or other invasive candidiasis at 30 days after end of study treatment, as determined by the DSMB
Time frame: Day 37 of study
Candidemia-attributable healthcare resources at 30 days after end of study treatment, including length of stay in ICU or IMC or general ward, duration of mechanical ventilation, cost of antifungal therapy since onset of candidemia
This is a composite outcome that will be analyzed descriptively only.
Time frame: Day 37 of study
Caspofungin-related adverse events (AEs) occurring until 30 days after last administration of caspofungin.
Time frame: From enrolment to Day 37 of study
Patient reported outcome measures (PROMs) on Day 1 and Day 37: Health-related quality of life per EQ-5D-5L + Physical fuctioning as per WHODAS 2.0
EQ-5D-5L = 5-level EQ-5D version WHODAS 2.0 = WHO Disability Assessment Schedule 2.0 EQ-5D-5L and WHODAS 2.0 are questionnaires that will yield point scores without units. Results will be analyzed descriptively as, all analysis will be carried out in accordance with standard of practice.
Time frame: Day 1 and Day 37 of study
Impact of age, sex, relevant comorbidities, SOFA and qSOFA score, use of vasopressors and Candida species on recurrence of candidemia
Exploratory Endpoint SOFA = sequential organ failure assessment qSOFA = quick sequential organ failure assessment Each potentially impacting factor will be analyzed separately.
Time frame: From enrolment to Day 37 of study
Plan to share: Yes — The IPD of all participants who have provided the relevant informed consent will be shared via the German Network of University Medicine (NUM). Access to the data will be governed and facilitated by the dedicated NUM infrastructure, the 'Dynamic Use \& Access Coordination Unit'.
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