Rezafungin Prophylaxis in Liver Transplant

Fernanda P Silveira, MD, MS

Status and phase: Invitation-only; Phase 3

Conditions: Fungal Infection; Liver Transplant Infection

Treatments: Drug: Rezafungin; Drug: Standard of care antifungal prophylaxis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06774144

STUDY24080165

Details and patient eligibility

About

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.

Full 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)

Enrollment: 385 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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385 participants in 3 patient groups

Prospective Intervention Cohort

Experimental group

Description:

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

Treatment:

Drug: Rezafungin

Prospective Control Cohort

Active Comparator group

Description:

Patients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of UPMC's risk-based antifungal prophylaxis standard of care after liver transplant

Treatment:

Drug: Standard of care antifungal prophylaxis

Historical Control Group

Active Comparator group

Description:

Patients at risk for IFI who received fluconazole/voriconazole for antifungal prophylaxis after liver transplant in the two years preceding the study

Treatment:

Drug: Standard of care antifungal prophylaxis