The goal of this clinical trial is to learn if amphotericin B works to treat breakthrough invasive fungal disease (IFD) in patients with hematological diseases who have received azole-based prophylaxis. It will also learn about the safety of amphotericin B in this population.
The main questions it aims to answer are:
1. What is the overall response rate (complete remission + partial remission) of amphotericin B in treating breakthrough IFD after azole prophylaxis? 2. What medical problems do participants have when taking amphotericin B? 3. What is the 6-week (42-day) overall survival rate after starting treatment?
This is a single-arm, prospective study. Participants will:
1. Receive intravenous liposomal amphotericin B (3-5 mg/kg daily) for 4-6 weeks. 2. Undergo weekly clinical and laboratory assessments, including serum G/GM tests, microbiology tests, and imaging (CT) at 2, 4, and 6 weeks. 3. Have safety monitoring including liver and kidney function, electrolytes, and ECG. 4. Be followed for treatment response and survival.
Age ≥ 18 years old.
Diagnosed with hematological diseases and receiving triazole prophylaxis.
Confirmed or suspected breakthrough invasive fungal disease (IFD) according to EORTC/MSG 2020 criteria.
Able to understand and sign the informed consent form voluntarily.
Severe liver or renal dysfunction (ALT/AST > 3×ULN, Cr > 2×ULN).
Known allergy to amphotericin B or any component of the study drug.
Pregnant or lactating women.
Severe underlying diseases with expected survival < 3 months.