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NOT YET RECRUITING
NCT06859671
PHASE3

A Randomized Study of a Short Duration Therapy for Candidemia

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

362

Start Date

2025-07-01

Completion Date

2027-09-01

Last Updated

2025-03-05

Healthy Volunteers

No

Conditions

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