Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOliver Cornely, MD
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
1. Any Candida-positive blood culture within 7 days prior to the start of study treatment, i.e. on Day -7 to Day -1.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Caspofungin only within the study
DrugSeven days of caspofungin on-study.
Caspofungin for 3 days within the study
Drug3 days of caspofungin followed by 4 days of placebo.
Placebo only within the study
DrugZero days of caspofungin on-study.
Placebo for 4 days within the study
Drug3 days of caspofungin followed by 4 days of placebo.
Treatment groups
420 Participants
are divided into 3 treatment groupsGroup A: Group A (7 days of caspofungin on-study)Experimental treatment 1 intervention
Group B: Group B (3 days of caspofungin followed by 4 days placebo on-study)Experimental treatment 2 interventions
Group C: Group C (7 days of placebo on-study)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
Time from randomization to recurrent candidemia and/or other proven invasive candidiasis
Time frame
From enrolment to Day 37 of study2
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".
Time frame
Day 7 of study3
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".
Time frame
Day 37 of study4
All-cause mortality at 30 days after end of study treatment (Day 37)
Time frame
Day 37 of studyOther outcomes
1
Impact of age, sex, relevant comorbidities, SOFA and qSOFA score, use of vasopressors and Candida species on recurrence of candidemia
Exploratory Endpoint SOFA = sequential organ failure assessment qSOFA = quick sequential organ failure assessment Each potentially impacting factor will be analyzed separately.
Time frame
From enrolment to Day 37 of studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Oliver Cornely, MD
Lead sponsor
University of Cologne
Sponsor institution
Nationales Referenzzentrum für Invasive Pilzinfektionen (NRZMyk)
Collaborator
Deutsche Sepsis-Hilfe e.V.
Collaborator
Netzwerk Universitätsmedizin (NUM)
Collaborator
University Medical Center Goettingen
Collaborator
Source ClinicalTrials.gov
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