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

Condition(s) studied

Investigational drug(s) / intervention(s)

Amphotericin B: Amphotericin 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Overall Response Rate of Antifungal Therapy at 6 Weeks (42 Days) — 6 weeks (42 days) after treatment initiation
  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.

Trial sites (1)

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