Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial

NCT07788586 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: uni-koeln-57452026-525640-14-00
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 24

Brief 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. 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.

Conditions

Candidemia; Invasive Candidiasis

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (8)

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

  From enrolment to Day 37 of study

• Clinical cure, radiological cure and mycological eradication at end of study treatment (Day 7)

  Day 7 of study

• Clinical cure, radiological cure and mycological eradication at 30 days after end of study treatment (Day 37)

  Day 37 of study

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

  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

  Day 37 of study

Other Outcomes (1)

• Impact of age, sex, relevant comorbidities, SOFA and qSOFA score, use of vasopressors and Candida species on recurrence of candidemia

  From enrolment to Day 37 of study

Study Arms (3)

Group A (7 days of caspofungin on-study)

EXPERIMENTAL

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 (3 days of caspofungin followed by 4 days placebo on-study)

EXPERIMENTAL

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 (7 days of placebo on-study)

EXPERIMENTAL

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

Interventions

Caspofungin only within the study DRUG

Seven days of caspofungin on-study.

Also known as: Cancidas

Group A (7 days of caspofungin on-study)

Caspofungin for 3 days within the study DRUG

3 days of caspofungin followed by 4 days of placebo.

Also known as: Cancidas

Group B (3 days of caspofungin followed by 4 days placebo on-study)

Placebo only within the study DRUG

Zero days of caspofungin on-study.

Group C (7 days of placebo on-study)

Placebo for 4 days within the study DRUG

3 days of caspofungin followed by 4 days of placebo.

Group B (3 days of caspofungin followed by 4 days placebo on-study)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Participants ≥18 years on the day of informed consent.
• \. Written informed consent by participant, according to applicable guidelines and laws.
• \. 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.
• \. Treatment with caspofungin for candidemia, initially proven by Candida-positive blood culture.
• \. 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.
• 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.

You may not qualify if:

• \. Any Candida-positive blood culture within 7 days prior to the start of study treatment, i.e. on Day -7 to Day -1.
• \. 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.
• \. Hematological malignancy without remission.
• \. Allogeneic hematopoietic stem-cell transplantation within 1 year prior to screening.
• \. Acute graft-versus-host disease grade III or IV.
• \. Hypersensitivity to caspofungin or any of the excipients.
• \. 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.
• \. Concomitant rifampin/rifampicin, phenytoin, carbamazepine, efavirenz or nevirapine during study participation.
• \. Absolute neutrophil count \<0.5 G/L at screening.
• \. Absolute neutrophil count \<0.5 G/L of any duration expected during study treatment.
• \. Child-Pugh score \>9 at screening.

Sponsors & Collaborators

• Oliver Cornely, MD: lead
• Nationales Referenzzentrum für Invasive Pilzinfektionen (NRZMyk): collaborator
• Deutsche Sepsis-Hilfe e.V.: collaborator
• Netzwerk Universitätsmedizin (NUM): collaborator
• University Medical Center Goettingen: collaborator

Study Sites (24)

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Uniklinik Köln

Cologne, 50937, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden an der Technischen Universität Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79110, Germany

Location

Universitätsklinikum Gießen und Marburg

Giessen, 35392, Germany

Location

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

Universitätsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Klinikum der Medizinischen Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum des Saarlandes

Homburg (Saar), 66421, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

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

Magdeburg, 39120, Germany

Location

LMU Klinikum

München, 81377, Germany

Location

Klinikum der Technischen Universität München (TUM Klinikum)

München, 81675, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Klinikum Oldenburg

Oldenburg, 26133, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Related Links

• CTIS Website

MeSH Terms

Conditions

Candidemia; Candidiasis, Invasive

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Central Study Contacts

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

CONTACT

+49 221 478 85523; oliver.cornely@uk-koeln.de

CanTEN Sponsor-Team

CONTACT

+49 221 478 67666; canten-sponsor@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med.

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (24)