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A multicenter, randomized, double-blind, placebo-controlled, adaptive, non-inferiority trial to investigate shortening treatment duration in uncomplicated candidemia: the CanTEN trial
EU CTIS ID: 2026-525640-14-00
What this study is testing
To demonstrate that shorter treatment courses are non-inferior to the current standard of 14 days after documented clearance of candidemia.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants ≥18 years on the day of informed consent.
- Written informed consent by participant or a legally acceptable representative, 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.
- 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 o first (since diagnosis of candidemia) Candida-negative blood-culture on Day -7 AND o 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: o 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. o Any implantable cardiac electronic device, ventricular assist device, extracorporeal membrane oxygenation support system, or indwelling intravascular foreign body must have been removed/replaced after 48 hours of the start of caspofungin treatment when candidemia was first diagnosed. o 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 likely can't join if
- Any Candida-positive blood culture within 7 days prior to the start of study treatment, i.e. on Day -7 to Day -1.
- Absolute neutrophil count <0.5 G/L of any duration expected during study treatment.
- Child-Pugh score >9 at screening.
- 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.
- Active intravenous illicit drug use.
- 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.
See the full eligibility criteria
Who can join
- Participants ≥18 years on the day of informed consent.
- Written informed consent by participant or a legally acceptable representative, 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.
- 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 o first (since diagnosis of candidemia) Candida-negative blood-culture on Day -7 AND o 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: o 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. o Any implantable cardiac electronic device, ventricular assist device, extracorporeal membrane oxygenation support system, or indwelling intravascular foreign body must have been removed/replaced after 48 hours of the start of caspofungin treatment when candidemia was first diagnosed. o 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.
What rules you out
- Any Candida-positive blood culture within 7 days prior to the start of study treatment, i.e. on Day -7 to Day -1.
- Absolute neutrophil count <0.5 G/L of any duration expected during study treatment.
- Child-Pugh score >9 at screening.
- 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.
- Active intravenous illicit drug use.
- 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.
- Previous participation in this trial.
- Person who is in a relationship of dependence/employment with the Sponsor or the investigator.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.