Clinical trial NCT06859671: A Randomized Study of a Short Duration Therapy for Candidemia
Official title: A Randomized Study of a Short Duration Therapy for Candidemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: CANDIDEMIA
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Design of the study Multicenter, controlled, randomized, non-inferiority, clinical trial with 2 parallel groups (1:1)
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: All-cause mortality (ACM)
timeFrame: At day 28
Secondary outcomes:
measure: Proportion of patients with secondary localizations
timeFrame: At day 28
measure: Cumulative incidence of death related to fungal infection
timeFrame: At day 28
measure: Aspartate Amino-transferase level
timeFrame: At day 14
measure: Aspartate Amino-transferase level
timeFrame: At day 28
measure: alanine aminotransférase (ALAT) level
timeFrame: At day 14
measure: alanine aminotransférase (ALAT) level
timeFrame: At day 28
measure: Gamma-Glutamyl Transférase (GGT) level
timeFrame: At day 14
measure: Gamma-Glutamyl Transférase (GGT) level
timeFrame: At day 28
measure: Bilirubin blood levels
timeFrame: At day 14
measure: Bilirubin blood levels
timeFrame: At day 28
measure: Cost per extra-day alive without antifungal treatment
timeFrame: Up to day 28
Other outcomes:
Locations:
Study officials:
References: