Liposomal Amphotericin B in Invasive Aspergillosis With Hepatic Dysfunction
NCT07337720 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-01-13
Summary
Liposomal amphotericin B is an antifungal agent commonly used to treat invasive aspergillosis, a severe fungal infection associated with high mortality in critically ill patients. However, evidence regarding its safety and effectiveness in patients with hepatic dysfunction is limited.
In China, patients diagnosed with invasive aspergillosis complicated by hepatic dysfunction will be recruited from multiple centers. Eligible patients will receive treatment with liposomal amphotericin B according to the study protocol. The safety and effectiveness of liposomal amphotericin B in this patient population will be evaluated.
This study aims to provide clinical evidence to support antifungal treatment decisions for patients with invasive aspergillosis and impaired liver function.
Conditions
- Aspergillosis Invasive
Interventions
- DRUG
-
LIposomal amphotericin B (L-AmB) treatment
Patients with invasive aspergillosis complicated by hepatic dysfunction who are admitted to the intensive care unit (ICU) will be treated with liposomal amphotericin B (L-AmB) at a dose of 3 mg/kg/day administered by intravenous infusion for 2 weeks. Patients will then enter a 4-week follow-up period. During the follow-up period, investigators may decide to continue treatment with liposomal amphotericin B or switch to other antifungal agents based on the patients' clinical condition.
Sponsors & Collaborators
-
Southeast University, China
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
- 2025-12-20
- Primary Completion
- 2026-12-20
- Completion
- 2027-03-20
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