Набор по приглашению NCT06774144

Rezafungin Prophylaxis in Liver Transplant

Фаза III С лечением Liver Transplant Infection Fungal Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Rezafungin, Standard of care antifungal prophylaxis.
Кому может быть актуально: Состояния в реестре: Liver Transplant Infection, Fungal Infection. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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)

Вмешательства

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

Первичные конечные точки

Incidence of proven and probable IFIs [Срок оценки: 90 days post-transplant]
Incidence of proven and probable breakthrough IFI [Срок оценки: While receiving rezafungin, voriconazole, or fluconazole]

Вторичные конечные точки (7)

Fungal-free survival [Срок оценки: 90 days and 6 months post-transplant]
Fungal colonization [Срок оценки: 90 days and 6 months post-transplant]
Graft rejection [Срок оценки: 90 days and 6 months post-transplant]
Graft loss [Срок оценки: 90 days 6 months post-transplant]
All-cause mortality [Срок оценки: 90 days 6 months post-transplant]
Number of participants with premature discontinuation of prophylaxis [Срок оценки: 90 days post-transplant]
Overall incidence of development of antifungal resistance [Срок оценки: Within 6 months of transplant]

Критерии участия

Критерии включения

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.