Rezafungin Prophylaxis in Liver Transplant

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• Mycoses 260

Keywords

• rezafungin
• liver transplant
• prophylaxis

Mycoses

260 studies on the registry are indexed under Mycoses; 37 are open to participants now.

This study's planned enrollment of 385 is above the median of 68 across 164 interventional studies indexed under Mycoses.

Lead sponsor

Fernanda P Silveira, MD, MS is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Study 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

  Drug: Rezafungin

• 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

  Drug: Standard of care antifungal prophylaxis

• 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

  Drug: Standard of care antifungal prophylaxis

Interventions

• DrugRezafungin

  Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV weekly for 4 weeks.

• DrugStandard 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 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.

  Also known as: Fluconazole, voriconazole, or no prophylaxis

Primary outcomes

1. Incidence of proven and probable IFIs

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

   Time frame: 90 days post-transplant

2. Incidence of proven and probable breakthrough IFI

   Incidence of breakthrough IFI while on specific antifungal prophylaxis

   Time frame: While receiving rezafungin, voriconazole, or fluconazole

Secondary outcomes

1. Fungal-free survival

   Number of participants without fungal infection

   Time frame: 90 days and 6 months post-transplant

2. Fungal colonization

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

   Time frame: 90 days and 6 months post-transplant

3. Graft rejection

   Number of participants with liver allograft acute rejection

   Time frame: 90 days and 6 months post-transplant

4. Graft loss

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

   Time frame: 90 days 6 months post-transplant

5. All-cause mortality

   Number of participants who die

   Time frame: 90 days 6 months post-transplant

6. Number of participants with premature discontinuation of prophylaxis

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

   Time frame: 90 days post-transplant

7. Overall incidence of development of antifungal resistance

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

   Time frame: Within 6 months of transplant

Other outcomes

1. Pharmakokinectics (PK) of rezafungin

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

   Time frame: Up to 4 weeks post-transplant

2. Stool microbiota composition

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

   Time frame: Within 6 months post-transplant

Individual participant data

Plan to share: No — We do not plan to share individual participant data outside of our investigative team and collaborators. Aggregate data will be shared in publications as appropriate.