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.
73 studies on the registry are indexed under Candidemia; 5 are open to participants now.
This study's planned enrollment of 420 is above the median of 63 across 44 interventional studies indexed under Candidemia.
Browse Candidemia studies →Oliver Cornely, MD is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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'.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Caspofungin