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CandidemiaPhase 4CanTENNCT07788586

Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial

A Phase 4 study testing Caspofungin only within the study and Caspofungin for 3 days within the study in people with Candidemia and Invasive Candidiasis, run by Oliver Cornely, MD at 24 sites in Germany.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Candidemia, Invasive Candidiasis
What is being tested?
Caspofungin only within the study and Caspofungin for 3 days within the study
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
24 sitesGermany
Study dates
Sep 2026to Feb 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Participants ≥18 years on the day of informed consent.
  • 2. Written informed consent by participant, according to applicable guidelines and laws.
  • 3. For female participants of child-bearing potential only: willingness to practice highly effective contraception or abstinence for the duration of the trial, i.e. until 30 days after end of study treatment. Highly effective contraception methods include sterilization, combined estrogen and progestogen-containing hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner. In case of nausea, diarrhoea or vomiting, oral contraception cannot be used; a non-oral highly effective method of contraception must be used instead.
  • 4. Treatment with caspofungin for candidemia, initially proven by Candida-positive blood culture.
  • 5. Uncomplicated candidemia defined as follows:
  • a. 7 consecutive days of caspofungin treatment after documented clearance of candidemia, i.e. caspofungin treatment on Day -7 to Day -1 prior to study treatment. Documented clearance of candidemia is defined as first (since diagnosis of candidemia) Candida-negative blood-culture on Day -7 AND no Candida-positive blood cultures from Day -6 to Day -1.
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  • b. Treatment is planned for another 7 days, i.e. for the entire duration of study treatment from Day 1 to Day 7. Please note there is no Day 0 in this study. Day -1 is directly followed by Day 1.
  • c. Less than 120 hours between the initial Candida-positive blood culture and the first Candida-negative blood-culture.
  • d. Source control for candidemia as follows:
  • Any central venous access device (e.g., central venous catheter, peripherally inserted central catheters, Shaldon catheters, Hickman and Broviac lines, or implanted port systems) must have been removed/replaced within 48 hours after the start of caspofungin treatment when candidemia was first diagnosed.
  • Any implantable cardiac electronic device, ventricular assist device, extracorporeal membrane oxygenation support system, or indwelling intravascular foreign body must have been removed/replaced within 48 hours after the start of caspofungin treatment when candidemia was first diagnosed.
  • Any intraabdominal candidiasis (e.g., intraabdominal abscess, peritonitis) must have been treated successfully within 5 days after start of treatment (caspofungin with or without surgery) when candidemia was first diagnosed.

Who cannot join

  • 1. Any Candida-positive blood culture within 7 days prior to the start of study treatment, i.e. on Day -7 to Day -1.
  • 2. Complicated candidemia defined by any of the following:
  • a. History of candidemia within 3 months prior to the current candidemia episode.
  • b. History or current presence of extra-abdominal deep-seated candidiasis, i.e. central nervous system infection, chorioretinitis, endophthalmitis, intravascular infection, endocarditis, renal abscess, osteomyelitis, or joint infection.
  • c. History of intra-abdominal candidiasis within 3 months prior to the current candidemia episode. Only exception: a very first episode of intra-abdominal candidiasis has been treated successfully within 5 days after the initial diagnosis of the current candidemia episode.
  • d. Candidemia caused by echinocandin-resistant Candida isolate.
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  • 3. Hematological malignancy without remission.
  • 4. Allogeneic hematopoietic stem-cell transplantation within 1 year prior to screening.
  • 5. Acute graft-versus-host disease grade III or IV.
  • 6. Hypersensitivity to caspofungin or any of the excipients.
  • 7. Ongoing glucocorticosteroids ≥0.3 mg/kg of prednisone equivalent per day at the initial diagnosis of the current candidemia episode with a planned cumulative administration of more than 3 weeks or ongoing administration of more than three weeks.
  • 8. Concomitant rifampin/rifampicin, phenytoin, carbamazepine, efavirenz or nevirapine during study participation.
  • 9. Absolute neutrophil count <0.5 G/L at screening.
  • 10. Absolute neutrophil count <0.5 G/L of any duration expected during study treatment.
  • 11. Child-Pugh score >9 at screening.
  • 12. Pregnant women and breastfeeding mothers. Prior to enrolment, pregnancy must be ruled out by a negative blood pregnancy test for all women of child-bearing potential.
  • 13. Active intravenous illicit drug use.
  • 14. Administration of an investigational drug (i.e. not yet authorized)
  • a. Within 30 days before the first dose of study treatment in this trial OR
  • b. Within five half-lives before the first dose of study treatment in this trial whichever is longer. An investigational drug is defined as a drug not authorized for any indication in the country where this trial is conducted.
  • 15. Previous participation in this trial.
  • 16. Person who is in a relationship of dependence/employment with the Sponsor or the investigator.

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Univ.-Prof. Dr. med. Oliver A. Cornely - CanTEN Sponsor Team contact

+49 221 478 67666

canten-sponsor@uk-koeln.de

24 sites in 1 country

Germany24 sites

  • Universitätsklinikum Aachen

    Aachen, 52074

    Tim-Philipp Simon, Prof. Dr. med.

    Miriam R. Haverkamp, Dr. med.

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

    Leif Erik Sander, Univ.-Prof. Dr. med.

    Leif Erik Sander, Univ.-Prof. Dr. med.

  • Uniklinik Köln

    Cologne, 50937

    Oliver A Cornely, Univ.-Prof. Dr. med.

    Oliver A Cornely, Univ.-Prof. Dr. med.

  • Universitätsklinikum Carl Gustav Carus Dresden an der Technischen Universität Dresden

    Dresden, 01307

    Katja de With, PD Dr. hum. biol. Dr. med.

    Katja de With, PD Dr. hum. biol. Dr. med.

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

    Hans Martin Orth, Dr. med.

    Hans Martin Orth, Dr. med.

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590

    Maria Vehreschild, Prof. Dr. med.

    Maria Vehreschild, Prof. Dr. med.

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79110

    Siegbert Rieg, Prof. Dr. med.

    Daniel Hornuß, Dr. med.

  • Universitätsklinikum Gießen und Marburg

    Giessen, 35392

    Janina Trauth, Dr. med.

    Susanne Herold, Prof. Dr. med.

  • Universitätsmedizin Göttingen

    Göttingen, 37075

    Alexander O König, PD Dr. med

    Christoph Ammer-Herrmenau, Dr. med.

  • Universitätsklinikum Halle (Saale)

    Halle, 06120

    Daniel Ebert, Dr. med.

    Daniel Ebert, Dr. med.

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Stefan Kluge, Prof. Dr. med.

    Dominik Jarczak, Dr. med.

  • Klinikum der Medizinischen Hochschule Hannover

    Hanover, 30625

    Susanne Simon, Dr. med.

    Susanne Simon, Dr. med.

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

    Markus A M Weigand, Univ.- Prof. Dr. med.

    Susanne Picardi, PD Dr. med.

  • Universitätsklinikum des Saarlandes

    Homburg (Saar), 66421

    Sören L Becker, Prof. Dr. med. Dr. phil.

    Sören L Becker, Prof. Dr. med. Dr. phil.

  • Universitätsklinikum Jena

    Jena, 07747

    Oana Joean, Dr. med.

    Stefan Hagel, PD Dr. med.

  • Universitätsklinikum Leipzig

    Leipzig, 04103

    Christoph Lübbert, Prof. Dr. med.

    Jasmin Tischer, Dr. med.

  • Universitätsklinik Magdeburg A. ö. R. / Medizinische Fakultät der Otto-von Guericke Universität Magdeburg

    Magdeburg, 39120

    Achim Kaasch, Prof. Dr. med.

    Achim Kaasch, Prof. Dr. med.

  • LMU Klinikum

    München, 81377

    Ulrich Seybold, PD Dr. med.

    Julia Roider

  • Klinikum der Technischen Universität München (TUM Klinikum)

    München, 81675

    Tobias Lahmer, Dr. med.

    Tobias Lahmer, Dr. med.

  • Universitätsklinikum Münster

    Münster, 48149

    Jonel Trebicka, Prof. Dr. med.

    Julia Fischer, Dr. med.

  • Klinikum Oldenburg

    Oldenburg, 26133

    Axel Hamprecht, Prof. Dr. med.

    Axel Hamprecht, Prof. Dr. med.

  • Universitätsklinikum Regensburg

    Regensburg, 93053

    Stephan Schmid, Prof Dr. med.

    Stephan Schmid, Prof. Dr. med.

  • Universitätsklinikum Ulm

    Ulm, 89081

    Beate Grüner, Prof. Dr. med.

    Beate Grüner, Prof. Dr. med.

  • Universitätsklinikum Würzburg

    Würzburg, 97080

    Nora Isberner, Dr. med.

    Andrew Ullmann, Prof. Dr. med.

Other trials in Germany

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Non-inferiority Trial to Investigate 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 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.

Being tested
Caspofungin only within the study, Caspofungin for 3 days within the study, Placebo only within the study, Placebo for 4 days within the study
Medical subject headings
Candidemia, Candidiasis, Invasive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caspofungin only within the studyDrug

    Also called Cancidas

    Seven days of caspofungin on-study.

  • Caspofungin for 3 days within the studyDrug

    Also called Cancidas

    3 days of caspofungin followed by 4 days of placebo.

  • Placebo only within the studyDrug

    Zero days of caspofungin on-study.

  • Placebo for 4 days within the studyDrug

    3 days of caspofungin followed by 4 days of placebo.

Study groups in NCT07788586
Study groupRoleWhat they receive
Group A (7 days of caspofungin on-study)ExperimentalGroup 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.
Receives: Drug: Caspofungin only within the study
Group B (3 days of caspofungin followed by 4 days placebo on-study)ExperimentalGroup 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.
Receives: Drug: Caspofungin for 3 days within the study; Drug: Placebo for 4 days within the study
Group C (7 days of placebo on-study)ExperimentalGroup 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.
Receives: Drug: Placebo only within the study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of recurrent candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment (Day 37)

    Measured: Day 37 of study (end of the study for the individual participant)

Secondary outcomes (8)

  1. Time from randomization to recurrent candidemia and/or other proven invasive candidiasis

    Measured: From enrolment to Day 37 of study

  2. 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".

    Measured: Day 7 of study

  3. 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".

    Measured: Day 37 of study

  4. All-cause mortality at 30 days after end of study treatment (Day 37)

    Measured: Day 37 of study

  5. Mortality attributable to candidemia and/or other invasive candidiasis at 30 days after end of study treatment, as determined by the DSMB

    Measured: Day 37 of study

  6. 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.

    Measured: Day 37 of study

  7. Caspofungin-related adverse events (AEs) occurring until 30 days after last administration of caspofungin.

    Measured: From enrolment to Day 37 of study

  8. 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.

    Measured: Day 1 and Day 37 of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
CanTEN is an adaptive, multi-armed interventional study. Initially, participants are randomized to Group A (7 days of caspofungin on-study) or Group B (3 days of caspofungin followed by 4 days placebo on-study). An interim analysis will be performed when 50% of participants, relative to the re-estimated total sample size per group, in each Group A and Group B have reached Day 37. Depending on the results, four scenarios are possible: 1. : Non-inferiority of Group B shown --\> Group A will be stopped, Group B will be continued, Group C (7 days of placebo on-study) will be started. 2. : Non-inferiority of Group B not shown, conditional power above threshold --\> Group A and Group B will be continued, Group C will be started. 3. : Non-inferiority of Group B not shown, conditional power below threshold --\> Group A and Group B will be continued, Group C will not be started. 4. : Futility demonstrated --\> Group A and Group B will be stopped, Group C will not be started, trial terminated.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07788586
Sponsor's protocol ID
uni-koeln-5745
Other IDs
2026-525640-14-00
Acronym
CanTEN
Status last verified
Aug 2026
First submitted
18 Aug 2026
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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'.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Caspofungin only within the study and Caspofungin for 3 days within the study in people with Candidemia and Invasive Candidiasis, run by Oliver Cornely, MD at 24 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Univ.-Prof. Dr. med. Oliver A. Cornely - CanTEN Sponsor Team (+49 221 478 67666, canten-sponsor@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07788586.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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