Rezafungin Prophylaxis in Liver Transplant at High Risk for Invasive Fungal Infection
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- Incidence of proven and probable IFIs
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Rezafungin (Drug)
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
干预措施: Standard of care antifungal prophylaxis (Drug)
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
干预措施: Standard of care antifungal prophylaxis (Drug)
结局指标
主要结局
Incidence of proven and probable IFIs
时间窗: 90 days post-transplant
Incidence of proven and probable IFIs within 90 days post-transplant
Incidence of proven and probable breakthrough IFI
时间窗: While receiving rezafungin, voriconazole, or fluconazole
Incidence of breakthrough IFI while on specific antifungal prophylaxis
次要结局
- Fungal-free survival(90 days and 6 months post-transplant)
- Fungal colonization(90 days and 6 months post-transplant)
- Graft rejection(90 days and 6 months post-transplant)
- Graft loss(90 days 6 months post-transplant)
- All-cause mortality(90 days 6 months post-transplant)
- Overall incidence of development of antifungal resistance(Within 6 months of transplant)
- Number of participants with premature discontinuation of prophylaxis(90 days post-transplant)
研究者
Fernanda P Silveira, MD, MS
Professor of Medicine
University of Pittsburgh