Amphotericin B for Breakthrough Fungal Infections After Triazole Prophylaxis in Hematological Patients

Starting soon · Not applicable

Conditions studied: Invasive Fungal Disease

In brief

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.

Key facts

Study ID

NCT07559032

Run by

Peking University People's Hospital

People needed

15

Starts

2026-04-01

Expected to finish

2028-12-31

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Peking University People's Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.