Clinical Trial

L-AmB_ Retrospective mUlticenter Study on Mycosis prOphylaxis

Study acronym: L-AmB_RUSCO
Enrolling by Invitation
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Record status
This record was last updated May 4, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Invasive fungal disease (IFD) still represents an important cause of morbidity and mortality in immunocompromised patients, particularly in patients undergoing antineoplastic chemotherapy or allogeneic hemopoietic stem cell transplantation (allo-HSCT). International guidelines recommend primary antifungal prophylaxis to reduce mortality and morbidity in these patients. Liposomal amphotericin B (L-AmB) can represent a valid alternative for antifungal prophylaxis in pediatric age as its spectrum is extended to both molds and yeasts, has reduced pharmacological interactions with the antineoplastic drugs most frequently used in treatment protocols. All this despite the availability of an intravenous formulation which can ensure complete compliance with the treatment. L-AmB prophylaxis has been proposed with different dosages: 1 mg/kg every other day vs 2.5 mg/kg/dose twice-a-week vs 5 mg/kg/once-a-week)
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-10.
Trial Details
NCT Number NCT06640296
Lead Sponsor Istituto Giannina Gaslini
Conditions Invasive Fungal Infections, Prophylaxis, Invasive Fungal Disease
Enrollment 120 participants
Start Date 2023-12-12
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-04