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ENROLLING BY INVITATION
NCT06640296

L-AmB_ Retrospective mUlticenter Study on Mycosis prOphylaxis

Sponsor: Istituto Giannina Gaslini

View on ClinicalTrials.gov

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)

Official title: Tolerability and Effectiveness of Extended Dosing of Liposomal Amphotericin B (L-AmB) for Primary Prophylaxis of Invasive Fungal Disease in High-risk Pediatric Patients: a Retrospective Multicenter Study

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2023-12-12

Completion Date

2026-05-31

Last Updated

2025-05-04

Healthy Volunteers

No

Interventions

DRUG

Liposomal Amphotericin B (LAmB)

collect data on tolerability and effectiveness of liposomal amphotericin B prophylaxis

Locations (1)

Istituto Giannina Gaslini

Genoa, Italy