2026-525640-14-00招募中4 期
A multicenter, randomized, double-blind, placebo-controlled, adaptive, non-inferiority trial to investigate shortening treatment duration in uncomplicated candidemia: the CanTEN trial
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 24
- 主要终点
- Rate of recurrent candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment (Day 37).
研究概览
简要总结
To demonstrate that shorter treatment courses are non-inferior to the current standard of 14 days after documented clearance of candidemia.
研究设计
- 分配方式
- Randomized
- 主要目的
- Trial phase
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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 -
- •b. Treatment is planned for another 7 days, i.e. for the entire duration of study treatment from Day 1 to Day
- •Please note there is no Day 0 in this study. Day -1 is directly followed by Day
- •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.
排除标准
- •Any Candida-positive blood culture within 7 days prior to the start of study treatment, i.e. on Day -7 to Day -
- •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.
结局指标
主要结局
Rate of recurrent candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment (Day 37).
Rate of recurrent candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment (Day 37).
次要结局
- Time from randomization to recurrent candidemia and/or other proven invasive candidiasis.
- Clinical cure, radiological cure and mycological eradication at end of study treatment (Day 7).
- Clinical cure, radiological cure and mycological eradication at 30 days after end of study treatment (Day 37).
- All-cause mortality at 30 days after end of study treatment (Day 37).
- Mortality attributable to candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment, as determined by the DSMB.
- 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.
- Caspofungin-related adverse events (AEs) occurring until 30 days after last administration of caspofungin.
- Patient reported outcome measures (PROMs) on Day 1 and Day 37: Health-related quality of life as per EQ-5D-5L , Physical functioning as per WHODAS 2.0.
研究者
CanTEN Sponsor Team
Scientific
University Of Cologne
研究点 (24)
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