Clinical Trial

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

Not Yet Recruiting
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07559032
Lead Sponsor Peking University People's Hospital
Conditions Invasive Fungal Disease
Enrollment 15 participants
Start Date 2026-04
Primary Completion 2028-12 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-30