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.
Single group
Amphotericin B
DrugAmphotericin B is a polyene antifungal drug used to treat breakthrough fungal infections. The dosage and duration will be determined based on pathogen results and clinical guidelines.
Overall Response Rate of Antifungal Therapy at 6 Weeks (42 Days)
The overall response rate will be assessed at 6 weeks (42 days) after the initiation of amphotericin B treatment, evaluated according to the EORTC/MSG 2020 criteria for invasive fungal disease, including complete response, partial response, stable disease, and progressive disease.
Overall Survival Rate at 6 Weeks
Proportion of participants alive at 6 weeks (42 days) after initiation of amphotericin B therapy.
Change in serum G test level
Change from baseline in serum (1,3)-β-D-glucan level. Unit of measure: pg/mL.
Change in serum GM test level
Change from baseline in serum galactomannan test value. Unit of measure: ug/L.
Microbiological clearance
Proportion of participants with negative conversion of baseline positive microbiological evidence (e.g., blood culture, sputum culture, mNGS, or site smear/culture).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
