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NCT07725874
Safety and Efficacy of Liposomal Amphotericin B for Patients With Invasive Mold Diseases in Liver Transplant Recipients
Conditions: Invasive Mold Diseases
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
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.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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 \
Source: ClinicalTrials.gov (NCT07725874). StuddyBuddy aggregates publicly available trial information.