Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fernanda P Silveira, MD, MS
With
Melinta Therapeutics
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)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
