Amphotericin B for Breakthrough Fungal Infections After Triazole Prophylaxis in Hematological Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amphotericin B.
- Who it may be relevant to
- Registry conditions: Invasive Fungal Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Prospective, Observational Study to Evaluate the Efficacy and Safety of Amphotericin B in the Treatment of Breakthrough Invasive Fungal Disease in Hematological Patients Receiving Triazole Prophylaxis
Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- Overall Response Rate of Antifungal Therapy at 6 Weeks (42 Days) [Time frame: 6 weeks (42 days) after treatment initiation]
Secondary outcome measures (12)
- Overall Survival Rate at 6 Weeks [Time frame: 6 weeks (42 days) after treatment initiation]
- Change in serum G test level [Time frame: From enrollment to the end of 6-week treatment]
- Change in serum GM test level [Time frame: From enrollment to the end of 6-week treatment]
- Microbiological clearance [Time frame: From enrollment to the end of 6-week treatment]
- Change in chest CT findings [Time frame: Baseline to 6 weeks after treatment initiation]
- Proportion of participants with treatment-emergent adverse events (AEs) [Time frame: From first dose to 30 days after last dose.]
- Proportion of participants discontinuing amphotericin B due to adverse events [Time frame: During treatment period (up to 6 weeks).]
- Change in serum alanine aminotransferase (ALT) [Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).]
- Change in serum aspartate aminotransferase (AST) [Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).]
- Change in serum total bilirubin [Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).]
- Change in serum creatinine [Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).]
- Change in serum electrolyte levels (potassium, sodium, calcium, magnesium) [Time frame: Baseline to end of treatment up to 6 weeks (twice weekly).]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07559032 · PKUPH20260411