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A Randomized Study of a Short Duration Therapy for Candidemia
Sponsor: Assistance Publique - Hôpitaux de Paris
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
Standard of Care (SOC)
14 days of antifungal therapy after the 1st negative blood culture
Shortened duration of antifungal therapy
7 days of antifungal therapy after the 1st negative blood culture