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.
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Single group
AmBisome (Amphotericin B) Liposome
DrugThis 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.
The primary endpoint of this study is the safety profile of liposomal amphotericin B (AmBisome) in liver transplant recipients with invasive mold disease
The primary endpoint of this study is to comprehensively evaluate the safety profile of liposomal amphotericin B (AmBisome) in liver transplant recipients diagnosed with invasive mold disease (IMD). Safety will be assessed by systematically monitoring the incidence, severity, timing, and outcomes of treatment-emergent adverse events (TEAEs) occurring during and after AmBisome therapy. Particular attention will be paid to adverse events of special interest associated with amphotericin B treatment, including nephrotoxicity, electrolyte disturbances (such as hypokalemia and hypomagnesemia), infusion-related reactions, hepatotoxicity, hematologic abnormalities, and other clinically significant laboratory abnormalities.
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