A Randomized Study of a Short Duration Therapy for Candidemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care (SOC), Shortened duration of antifungal therapy.
- Who it may be relevant to
- Registry conditions: CANDIDEMIA. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Scientific justification Candidemia is a major public health problem. In France, the 30-day mortality of candidemia varies from 30% to 50% depending on the need for intensive care and it has not decreased in 30 years. The duration of treatment for candidemia was set at a minimum of 14 days after the last positive blood culture following the Rex trial (1) comparing the efficacy of fluconazole vs amphotericin B where the minimum duration of treatment was imposed. The risk of a too short treatment is the absence of control of the candidemia with secondary dissemination, in particular cardiac and ophthalmic. A retrospective study looking at the risk of ophthalmologic complications after candidemia found among the 21/78 treated for less than 14 days, only one case of late endophthalmitis in a patient who had only been treated for 48 hours. In addition, the prolonged duration of antifungals exposes the risk of selection of more resistant strains with a modification of the flora, with the possibility of acquiring resistance as early as 8 days of treatment with caspofungin, and has a greater liver toxicity. There is no prospective study on the direct impact of antifungal agents (type of antifungal agent and duration) on the mycobiota.
Interventions
- Drug Standard of Care (SOC)
14 days of antifungal therapy after the 1st negative blood culture - Drug Shortened duration of antifungal therapy
7 days of antifungal therapy after the 1st negative blood culture
Primary outcome measures
- All-cause mortality (ACM) [Time frame: At day 28]
Secondary outcome measures (11)
- Proportion of patients with secondary localizations [Time frame: At day 28]
- Cumulative incidence of death related to fungal infection [Time frame: At day 28]
- Aspartate Amino-transferase level [Time frame: At day 14]
- Aspartate Amino-transferase level [Time frame: At day 28]
- alanine aminotransférase (ALAT) level [Time frame: At day 14]
- alanine aminotransférase (ALAT) level [Time frame: At day 28]
- Gamma-Glutamyl Transférase (GGT) level [Time frame: At day 14]
- Gamma-Glutamyl Transférase (GGT) level [Time frame: At day 28]
- Bilirubin blood levels [Time frame: At day 14]
- Bilirubin blood levels [Time frame: At day 28]
- Cost per extra-day alive without antifungal treatment [Time frame: Up to day 28]
Eligibility criteria
Inclusion criteria
- Adults (Age ≥ 18 years old)
- With an uncomplicated candidemia defined by the absence of secondary sites requiring prolonged treatment: endocarditis, ophthalmologic involvement, thrombosed catheter, arthritis, meningitis, candida abscess that cannot be drained, pyelonephritis.
- Without expected aplasia duration greater than 7 days
- Being apyretic and having a 1st negative blood culture after diagnosis
- Removal of the vascular catheter if present
- Written informed consent from the patients or his/her relatives
- Patients with less than 7 days of aplasia predictable
Exclusion criteria
- Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or the presence of secondary sites of candidemia requiring prolonged treatment
- Patients with more than 7 days of aplasia
- Candida strain resistant to the antifungal used
- Pregnancy, breastfeeding
- Hypersensitivity or previous severe adverse drug reaction to the antifungal treatments.
- unwilling, in the judgment of the investigator, to comply with the protocol
- Patient under legal guardianship or without healthcare coverage
- Women with childbearing potential not using adequate contraception
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06859671 · APHP230824