Rezafungin Prophylaxis in Liver Transplant

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Fernanda P Silveira, MD, MS
Study ID
NCT06774144
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Fungal Infection
  • Liver Transplant Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rezafungin — DRUG
    Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV weekly for 4 weeks.
  • Standard of care antifungal prophylaxis — DRUG
    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 therapy, fulminant hepatic failure as indication for transplant, intra-abdominal/thoracic re-exploration within the first month after transplant. No prophylaxis is given if there are no risk factors for yeast or mould infections.

Study Details

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.

Key Dates

Start date
Oct 15, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
385 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Prospective Intervention Cohort
    Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV once weekly for a total duration of 4 weeks
  • Active Comparator: Prospective Control Cohort
    Patients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of UPMC's risk-based antifungal prophylaxis standard of care after liver transplant
  • Active Comparator: Historical Control Group
    Patients at risk for IFI who received fluconazole/voriconazole for antifungal prophylaxis after liver transplant in the two years preceding the study

Primary Outcome Measure

Incidence of proven and probable IFIs [ Time Frame: 90 days post-transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC PresbyterianPittsburghPennsylvania15213-

Find similar trials in Pittsburgh, PA

By research site
UPMC Presbyterian· Pittsburgh, PA

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