A Randomized Open-Label Trial of Caspofungin Versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)

This randomized phase III trial compares the effectiveness of caspofungin to fluconazole in
preventing invasive fungal infections in patients receiving chemotherapy for acute myeloid
leukemia (AML). Antifungal prophylaxis is considered standard of care in children and adults
with prolonged neutropenia after chemotherapy for AML however the ideal antifungal agent for
prophylaxis in children is not known. Caspofungin has activity against yeast and some molds
while fluconazole coverage is limited to just yeasts. Adult randomized trials suggest that
agents with activity against yeasts and molds are more effective than those with just
activity against yeasts. There are limited data to answer this comparative question in
children. This study will establish much needed pediatric data to guide clinical decision
making on optimal antifungal prophylaxis.