[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06774144":3,"trial-entities:NCT06774144":117,"trial-summary:NCT06774144":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":47,"secondary_outcomes":56,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":15,"eligibility_criteria":84,"std_ages":96,"locations":99,"central_contacts":109,"overall_officials":110,"references":115,"see_also_links":116},"NCT06774144","STUDY24080165","Rezafungin Prophylaxis in Liver Transplant","Rezafungin Prophylaxis in Liver Transplant at High Risk for Invasive Fungal Infection","ENROLLING_BY_INVITATION","2028-12","2025-10","2025-10-20","2025-10-15","Fernanda P Silveira, MD, MS","OTHER",false,"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.","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.\n\nThere will be 3 groups:\n\n1. Study group (prospective intervention cohort): Rezafungin (180 patients)\n2. Prospective control group (prospective control cohort): Patients who receive fluconazole\u002Fvoriconazole or no antifungal prophylaxis as part of UPMC's tiered antifungal prophylaxis standard of care (20 patients: 10 who receive fluconazole\u002Fvoriconazole and 10 who do not receive fluconazole\u002Fvoriconazole)\n3. Historical control group (retrospective control cohort): Patients at risk for IFI who received fluconazole\u002Fvoriconazole (tier approach) in the two years preceding this study (180 patients)",[19,20],"Liver Transplant Infection","Fungal Infection",[22,23,24],"rezafungin","liver transplant","prophylaxis","INTERVENTIONAL","PREVENTION",[28],"PHASE3",{"count":30,"type":31},385,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","Rezafungin","Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV weekly for 4 weeks.",[38],"Prospective Intervention Cohort",{"type":34,"name":40,"description":41,"armGroupLabels":42,"otherNames":45},"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 therapy, fulminant hepatic failure as indication for transplant, intra-abdominal\u002Fthoracic re-exploration within the first month after transplant. No prophylaxis is given if there are no risk factors for yeast or mould infections.",[43,44],"Historical Control Group","Prospective Control Cohort",[46],"Fluconazole, voriconazole, or no prophylaxis",[48,52],{"measure":49,"description":50,"timeFrame":51},"Incidence of proven and probable IFIs","Incidence of proven and probable IFIs within 90 days post-transplant","90 days post-transplant",{"measure":53,"description":54,"timeFrame":55},"Incidence of proven and probable breakthrough IFI","Incidence of breakthrough IFI while on specific antifungal prophylaxis","While receiving rezafungin, voriconazole, or fluconazole",[57,61,64,67,71,74,77],{"measure":58,"description":59,"timeFrame":60},"Fungal-free survival","Number of participants without fungal infection","90 days and 6 months post-transplant",{"measure":62,"description":63,"timeFrame":60},"Fungal colonization","Number of participants with presence or growth of fungi without it causing active infection or disease",{"measure":65,"description":66,"timeFrame":60},"Graft rejection","Number of participants with liver allograft acute rejection",{"measure":68,"description":69,"timeFrame":70},"Graft loss","Number of participants with failure of the liver allograft to function adequately or to remain viable","90 days 6 months post-transplant",{"measure":72,"description":73,"timeFrame":70},"All-cause mortality","Number of participants who die",{"measure":75,"description":76,"timeFrame":51},"Number of participants with premature discontinuation of prophylaxis","Number of patients who experience an adverse event requiring premature discontinuation of antifungal prophylaxis",{"measure":78,"description":79,"timeFrame":80},"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","Within 6 months of transplant","ALL","18 Years",null,{"inclusion":85,"exclusion":89,"raw_text":95},[86,87,88],"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.",[90,91,92,93,94],"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.","Inclusion Criteria:\n\n* Liver transplant recipient\n* 18 years of age or older\n* ≥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.\n\nExclusion Criteria:\n\n* Participants who are perceived not to survive past 7 days after transplant\n* Participants who elect not to participate in the prospective trial\n* Participants who had active candidiasis at the time of transplant\n* Participants with a history of allergy to an echinocandin\n* Participants who are pregnant.",[97,98],"ADULT","OLDER_ADULT",[100],{"facility":101,"city":102,"state":103,"zip":104,"country":105,"geoPoint":106},"UPMC Presbyterian","Pittsburgh","Pennsylvania","15213","United States",{"lat":107,"lon":108},40.44062,-79.99589,[],[111],{"name":112,"affiliation":113,"role":114},"Fernanda Silveira","University of Pittsburgh","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":118,"biomarkers":120},[20,119],"Liver Transplantation",[],{"nct_id":4,"found":15,"summary":83,"prompt_version":83}]