Safety and Efficacy of Liposomal Amphotericin B for Patients With Invasive Mold Diseases in Liver Transplant Recipients

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Conditions studied: Invasive Mold Diseases

In brief

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 facts

Study ID: NCT07725874
Run by: Beijing Friendship Hospital
People needed: 60
Starts: 2026-08-08
Expected to finish: 2028-08-15
Last updated by the study team: 2026-07-24

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients aged ≥12 years. Liver transplant recipients. Proven or probable invasive mold disease (IMD) according to the 2020 EORTC/MSGERC criteria.
Have received at least one dose of liposomal amphotericin B (AmBisome) or voriconazole.

You may not qualify if…

History of invasive mold disease previously treated with amphotericin B for more than 5 days.
Documented hypersensitivity or allergy to amphotericin B formulations. Sequential Organ Failure Assessment (SOFA) score >15. Expected survival <72 hours. Pregnant or breastfeeding. Patients who, in the investigator's judgment, are unable to complete the study treatment or follow the study protocol.
Recipients of combined organ transplantation or multivisceral transplantation.

Full record on ClinicalTrials.gov

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