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Enrolling by invitation NCT06774144

Rezafungin Prophylaxis in Liver Transplant

Phase III Interventional Liver Transplant Infection Fungal Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rezafungin, Standard of care antifungal prophylaxis.
Who it may be relevant to
Registry conditions: Liver Transplant Infection, Fungal Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Rezafungin Prophylaxis in Liver Transplant at High Risk for Invasive Fungal Infection

Overview

This is an interventional study to evaluate the efficacy of rezafungin, a new echinocandin, for the prevention of invasive fungal infections (IFIs) after liver transplantation. Patients who receive rezafungin will be compared to a similar group of patients who underwent liver transplantation in the preceding two years for the incidence of IFIs.

Detailed description

This is a single arm interventional study of consecutive liver transplant recipients who have consented to this rezafungin prophylaxis study. The outcome will be compared with that of similar group of patients not enrolled in the study and those who underwent liver transplant in the preceding two years (historical controls). Propensity score matching will be used to select retrospective cohort.

There will be 3 groups:

1. Study group (prospective intervention cohort): Rezafungin (180 patients) 2. Prospective control group (prospective control cohort): Patients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of UPMC's tiered antifungal prophylaxis standard of care (20 patients: 10 who receive fluconazole/voriconazole and 10 who do not receive fluconazole/voriconazole) 3. Historical control group (retrospective control cohort): Patients at risk for IFI who received fluconazole/voriconazole (tier approach) in the two years preceding this study (180 patients)

Interventions

  • Drug Rezafungin
    Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV weekly for 4 weeks.
  • Drug Standard of care antifungal prophylaxis
    UPMC uses a tiered approach to antifungal prophylaxis, based on risk factors for IFI. Fluconazole is used for recipients with risk factors for yeast infections: choledochojejunostomy, prolonged transplant time, receipt of \>40 units of blood products within 24 hours of transplant, and Candida colonization or infection within 3 months prior to transplant. Voriconazole is used for recipients with risk factors for mould infections: re-transplantation, renal failure requiring renal replacement thera

Primary outcome measures

  • Incidence of proven and probable IFIs [Time frame: 90 days post-transplant]
  • Incidence of proven and probable breakthrough IFI [Time frame: While receiving rezafungin, voriconazole, or fluconazole]
Secondary outcome measures (7)
  • Fungal-free survival [Time frame: 90 days and 6 months post-transplant]
  • Fungal colonization [Time frame: 90 days and 6 months post-transplant]
  • Graft rejection [Time frame: 90 days and 6 months post-transplant]
  • Graft loss [Time frame: 90 days 6 months post-transplant]
  • All-cause mortality [Time frame: 90 days 6 months post-transplant]
  • Number of participants with premature discontinuation of prophylaxis [Time frame: 90 days post-transplant]
  • Overall incidence of development of antifungal resistance [Time frame: Within 6 months of transplant]

Eligibility criteria

Inclusion criteria

  • Liver transplant recipient
  • 18 years of age or older
  • ≥1 risk factor(s) for IFI: living donor transplant, retransplantation, complicated operations (based on duration of transplant and number of blood products required in the peri-transplant period), choledochojejunostomy anastomosis, or peri-operative Candida colonization, recent Candida infection, renal replacement therapy post-transplant, and reoperation within the first 90 days of transplant.

Exclusion criteria

  • Participants who are perceived not to survive past 7 days after transplant
  • Participants who elect not to participate in the prospective trial
  • Participants who had active candidiasis at the time of transplant
  • Participants with a history of allergy to an echinocandin
  • Participants who are pregnant.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • UPMC Presbyterian — Pittsburgh

Identifiers

NCT: NCT06774144 · STUDY24080165

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗