Safety and Efficacy of Liposomal Amphotericin B for Patients With Invasive Mold Diseases in Liver Transplant Recipients | NCT07725874

NCT07725874

Overview

NCT ID: NCT07725874
Lead Sponsor: Beijing Friendship HospitalOTHER
Official Title: Safety and Efficacy of Liposomal Amphotericin B for Patients With Invasive Mold Diseases in Liver Transplant Recipients
Brief 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.
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Aug 8, 2026Estimated
Primary Completion Date: May 15, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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 <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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Similar Studies

Participant Group/Arms

evaluate the safety of liposomal amphotericin B (AmBisome) in liver transplant recipients with IMDExperimental

This study aims to describe the safety profiles and clinical characteristics of liposomal amphotericin B (AmBisome) or voriconazole as first-line therapies for invasive mold disease (IMD) in liver transplant recipients, utilizing historical matched-control analysis across 10 study sites. Specifically, a 1:2 propensity score matching (PSM) method will be applied to compare the prospectively enrolled AmBisome group (60 patients) with a historical voriconazole group (120 patients). The primary safety endpoints include: nephrotoxicity, hepatotoxicity, hypokalemia, cardiotoxicity (QT interval changes), infusion-related reactions, tacrolimus dose and trough concentration changes, and treatment-related serious adverse events leading to discontinuation or death (graded per CTCAE v5.0).

Drug: AmBisome (Amphotericin B) Liposome