Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06774144

Rezafungin Prophylaxis in Liver Transplant

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

About this study

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:

  • Study group (prospective intervention cohort): Rezafungin (180 patients)
  • 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)
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Fluconazole, voriconazole, or no prophylaxis

Primary outcomes

  1. Incidence of proven and probable IFIs

    Time frame: 90 days post-transplant

    Incidence of proven and probable IFIs within 90 days post-transplant

  2. Incidence of proven and probable breakthrough IFI

    Time frame: While receiving rezafungin, voriconazole, or fluconazole

    Incidence of breakthrough IFI while on specific antifungal prophylaxis

Secondary outcomes

  1. Fungal-free survival

    Time frame: 90 days and 6 months post-transplant

    Number of participants without fungal infection

  2. Fungal colonization

    Time frame: 90 days and 6 months post-transplant

    Number of participants with presence or growth of fungi without it causing active infection or disease

  3. Graft rejection

    Time frame: 90 days and 6 months post-transplant

    Number of participants with liver allograft acute rejection

  4. Graft loss

    Time frame: 90 days 6 months post-transplant

    Number of participants with failure of the liver allograft to function adequately or to remain viable

  5. All-cause mortality

    Time frame: 90 days 6 months post-transplant

    Number of participants who die

  6. Number of participants with premature discontinuation of prophylaxis

    Time frame: 90 days post-transplant

    Number of patients who experience an adverse event requiring premature discontinuation of antifungal prophylaxis

  7. Overall incidence of development of antifungal resistance

    Time frame: Within 6 months of transplant

    Antifungal resistance of breakthrough fungal organisms or fungal organisms recovered within the first 6 months of transplant for patients who received rezafungin

Other outcomes

  1. Pharmakokinectics (PK) of rezafungin

    Time frame: Up to 4 weeks post-transplant

    Pharmacokinetics of rezafungin while in ICU to assess the PK during the peri-transplant period

  2. Stool microbiota composition

    Time frame: Within 6 months post-transplant

    Stool microbiota and fecal Candida constituent and susceptibility profile in response to rezafungin

Sponsors and collaborators

Lead sponsor

Fernanda P Silveira, MD, MS

Other

Collaborators

  • Melinta Therapeutics

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 14, 2025
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.