L-AmB_ Retrospective mUlticenter Study on Mycosis prOphylaxis

Condition(s) studied

Investigational drug(s) / intervention(s)

Liposomal Amphotericin B (LAmB): collect data on tolerability and effectiveness of liposomal amphotericin B prophylaxis

Study 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)

Eligibility

Primary outcome measure(s)

• Tolerability of extended dosing of liposomal amphotericin B — In the period between the first and last administration of L-AmB
  Number of participants with treatment-related adverse events (both clinical and laboratoristic adverse events) as assessed by CTCAE v4.0

Trial sites (1)

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