A Randomized Study of a Short Duration Therapy for Candidemia

NCT ID: NCT06859671

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-09-01

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.

Conditions

CANDIDEMIA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

14 days of antifungal treatment

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: DRUG

14 days of antifungal therapy after the 1st negative blood culture

7 days of antifungal treatment

Group Type: EXPERIMENTAL

Shortened duration of antifungal therapy

Intervention Type: DRUG

7 days of antifungal therapy after the 1st negative blood culture

Interventions

Standard of Care (SOC)

14 days of antifungal therapy after the 1st negative blood culture

Intervention Type: DRUG

Shortened duration of antifungal therapy

7 days of antifungal therapy after the 1st negative blood culture

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Blandine Denis, MD

Role: CONTACT

blandine.denis@aphp.fr

+33142494585 ext. +33

Jérôme Lambert, MD PhD

Role: CONTACT

jerome.lambert@u-paris.fr

+33 1 42 49 97 42 ext. +33

Other Identifiers

APHP230824

Identifier Type: -

Identifier Source: org_study_id