A Randomized Study of a Short Duration Therapy for Candidemia (CANDISHORT)

Assistance Publique - Hôpitaux de Paris

Status and phase

Not yet enrolling

Phase 3

Conditions

CANDIDEMIA

Treatments

Drug: Shortened duration of antifungal therapy

Drug: Standard of Care (SOC)

Study type

Interventional

Funder types

Other

Identifiers

NCT06859671

APHP230824

Details and patient eligibility

About

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.

Enrollment

362 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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