UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT06774144
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Pittsburgh, Pennsylvania, 15213, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV weekly for 4 weeks.
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.
Other names: Fluconazole, voriconazole, or no prophylaxis
Time frame: 90 days post-transplant
Incidence of proven and probable IFIs within 90 days post-transplant
Time frame: While receiving rezafungin, voriconazole, or fluconazole
Incidence of breakthrough IFI while on specific antifungal prophylaxis
Time frame: 90 days and 6 months post-transplant
Number of participants without fungal infection
Time frame: 90 days and 6 months post-transplant
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
Number of participants with liver allograft acute rejection
Time frame: 90 days 6 months post-transplant
Number of participants with failure of the liver allograft to function adequately or to remain viable
Time frame: 90 days 6 months post-transplant
Number of participants who die
Time frame: 90 days post-transplant
Number of patients who experience an adverse event requiring premature discontinuation of antifungal prophylaxis
Time frame: Within 6 months of transplant
Antifungal resistance of breakthrough fungal organisms or fungal organisms recovered within the first 6 months of transplant for patients who received rezafungin
Time frame: Up to 4 weeks post-transplant
Pharmacokinetics of rezafungin while in ICU to assess the PK during the peri-transplant period
Time frame: Within 6 months post-transplant
Stool microbiota and fecal Candida constituent and susceptibility profile in response to rezafungin
Fernanda P Silveira, MD, MS
Other
Rezafungin Prophylaxis in Liver Transplant at High Risk for Invasive Fungal Infection
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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