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

NCT07559032 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-04-30

No results posted yet for this 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.

Conditions

  • Invasive Fungal Disease

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.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07559032 on ClinicalTrials.gov