Evaluation of Low-Dose Liposomal Amphotericin B for Preventing Fungal Infections in Children Aged 3 to 17 with Prolonged Neutropenia and Blood Cancers

What this Trial Is About

Researchers are evaluating the use of low-dose liposomal amphotericin B to prevent invasive fungal infections in children aged 3 to 17 years with blood cancers who develop prolonged neutropenia. This observational study focuses on children at high risk for these serious fungal infections who have intolerance or toxicity to other antifungal treatments. The study aims to assess the incidence of proven or probable invasive fungal disease and other related health outcomes. Participants receive liposomal amphotericin B at a dose of 1 mgkg per day, given intravenously once daily. This regimen is designed to maintain continuous drug exposure during the high-risk neutropenic period. The study is single-arm and collects data at three points baseline before treatment, during the treatment period, and within seven days after treatment ends. Throughout the study, researchers will monitor blood counts, biochemistry, lung imaging, and microbiological tests to detect fungal infections and related complications. They will also record episodes of fever, pneumonia, additional antifungal therapy use, and any adverse effects. The primary outcome is the rate of invasive fungal disease, with secondary outcomes including pneumonia incidence, persistent fever, need for extra antifungal treatment, and safety assessments. The total participation lasts from before treatment until one week after treatment completion.

Low-Dose Liposomal Amphotericin B for Invasive Fungal Infection Prophylaxis in Neutropenic Children