• Pilot Feasibility Study With Patients Who Are at High Risk For Developing Invasive Candidiasis in a Critical Care Setting (MK-0991-067)

  NCT01045798

  TerminatedInterventionalPhase 2Updated Mar 24, 2017
• CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension

  NCT02734862

  CompletedInterventionalPhase 2Updated Dec 8, 2020
• A Randomized Study of a Short Duration Therapy for Candidemia

  NCT06859671

  Not yet recruitingInterventionalPhase 3Updated Mar 5, 2025
• Comparison of Uncomplicated Candidemia Therapy Duration in Children

  NCT05763251

  RecruitingInterventionalNot ApplicableUpdated Apr 17, 2026
• A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)

  NCT00250432

  CompletedInterventionalPhase 3Updated Mar 24, 2017
• Caspofungin to Prevent Candidiasis in Adults in Hospital Intensive Care Units

  NCT00099775

  CompletedInterventionalPhase 3Updated Mar 4, 2008

ClinicalTrials.gov ID

NCT07788586

Lead Sponsor

Oliver Cornely, MDOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

420Estimated

Last Update Posted

Aug 26, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Feb 2028Estimated

Completion Date

Feb 2028Estimated

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Non-inferiority Trial to Investigate Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial

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.

• Candidemia
• Invasive Candidiasis

• Caspofungin only within the study
• Caspofungin for 3 days within the study
• Placebo only within the study
• Placebo for 4 days within the study

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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.
• 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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Oliver Cornely, MDOTHER

Collaborators

Nationales Referenzzentrum für Invasive Pilzinfektionen (NRZMyk)UNKNOWN

Deutsche Sepsis-Hilfe e.V.UNKNOWN

Netzwerk Universitätsmedizin (NUM)UNKNOWN

University Medical Center GoettingenOTHER

leif-erik.sander@charite.de+49 30 450 553332

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

hansmartin.orth@med.uni-duesseldorf.de+49 211 81 17031

alexander.koenig@med.uni-goettingen.de+49 551 39 63881

daniel.ebert@uk-halle.de+49 345 557 5148

Markus.Weigand@med.uni-heidelberg.de+49 6221 568837

oana.joean@med.uni-jena.de+49 3641 9324695

christoph.luebbert@medizin.uni-leipzig.de+49 341 9724970

Ulrich.Seybold@med.uni-muenchen.de+49 89 4400 53550

Jonel.Trebicka@ukmuenster.de+49 251 8359689

axel.hamprecht@uol.de+49 441 4032610

stephan.schmid@ukr.de+49 941 9447001

beate.gruener@uniklinik-ulm.de+49 731 500 45551

Isberner_N@ukw.de+49 931 201 44925