Rezafungin for Liver Transplant Infection

Overseen By Fernanda Silveira, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Fernanda P Silveira, MD, MS

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Fernanda Silveira

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals who have recently undergone a liver transplant and are at risk of developing invasive fungal infections. Participants should not have had any prior antifungal prophylaxis that would interfere with the study.

Inclusion Criteria

I have received a liver transplant.

I am 18 years old or older.

I have risk factors for fungal infections after my transplant.

Exclusion Criteria

Participants perceived not to survive past 7 days after transplant

Participants with a history of allergy to an echinocandin

Pregnant participants

Treatment Details

Interventions

• Rezafungin (Echinocandin)

Trial Overview The study tests rezafungin, a new medication, against standard antifungal treatments to prevent fungal infections after liver transplantation. Patients will be randomly assigned to receive either rezafungin or the standard care and monitored for infection rates.

Participant Groups

Group I: Prospective Intervention Cohort Experimental Treatment 1 Intervention

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

Group II: Prospective Control Cohort Active Control 1 Intervention

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

Group III: Historical Control Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Fernanda P Silveira, MD, MS

Lead Sponsor

Trials

2

Recruited

400+

Melinta Therapeutics

Industry Sponsor

Trials

1

Recruited

390+