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Safety and Efficacy of Liposomal Amphotericin B for Patients With Invasive Mold Diseases in Liver Transplant Recipients
Sponsor: Beijing Friendship Hospital
Summary
Invasive mold diseases (IMD) carry extremely high mortality rates in liver transplant recipients (aspergillosis prevalence \~1.8%, mortality 60%-90%; mucormycosis prevalence \~2%, mortality 38%-95%). Guidelines emphasize early antifungal therapy: liposomal amphotericin B (L-AmB) is the first-line choice in liver insufficiency; voriconazole remains the gold standard for aspergillosis (but ineffective against mucormycosis), yet its use is limited by significant drug-drug interactions-requiring a 50%-60% dose reduction of calcineurin inhibitors and contraindicated with sirolimus-thereby increasing the risk of graft rejection. Currently, no head-to-head clinical trials compare voriconazole and L-AmB in liver transplant recipients with IMD. Therefore, a prospective real-world study is planned to generate robust data to support updates to international or Chinese guidelines.
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-08-08
Completion Date
2028-08-15
Last Updated
2026-07-24
Healthy Volunteers
No
Conditions
Interventions
AmBisome (Amphotericin B) Liposome
This intervention is applied prospectively to the AmBisome group (target enrollment: 60 patients). The study does not mandate a fixed dose or fixed course length; rather, it reflects real-world clinical practice. All safety parameters (hepatotoxicity, nephrotoxicity, hypokalemia, cardiotoxicity, infusion reactions, tacrolimus dose/concentration changes, and serious adverse events) are longitudinally monitored during the intervention period.