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

Peking University

Status: Not yet enrolling

Conditions: Invasive Fungal Disease

Treatments: Drug: Amphotericin B

Study type: Interventional

Funder types: Other

Identifiers

NCT07559032

PKUPH20260411

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old.
2. Diagnosed with hematological diseases and receiving triazole prophylaxis.
3. Confirmed or suspected breakthrough invasive fungal disease (IFD) according to EORTC/MSG 2020 criteria.
4. Able to understand and sign the informed consent form voluntarily.

Exclusion criteria

1. Severe liver or renal dysfunction (ALT/AST > 3×ULN, Cr > 2×ULN).
2. Known allergy to amphotericin B or any component of the study drug.
3. Pregnant or lactating women.
4. Severe underlying diseases with expected survival < 3 months.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Amphotericin B Treatment

Experimental group

Treatment:

Drug: Amphotericin B