A Comparison of Anti-Fungal Medication Levels in Tissue and Serum in the Setting of Organ Procurement and Transplantation
This study compares the use of an anti-fungal drug, Eraxis, at different intervals in 10 liver recipients and 10 liver donors. The study will allow us to understand the metabolism of this anti-fungal drug and ultimately to provide insight into fungal infection prevention.
- Comparison of the ratio of tissue to serum concentrations, and tissue levels of anidulafungin in the hepatically impaired population.
- Comparison of the ratio of tissue to serum concentrations, and tissue levels of anidulafungin in organ donors.
- Comparison of the ratio of tissue to serum concentrations, and tissue levels of anidulafungin between the hepatically impaired population, and the organ donors.
- Comparison of the ratio of tissue to serum concentrations, and tissue levels of anidulafungin between participants receiving early vs. late administration of the medication.
- Examination of recipient outcomes - including infection rates, patient complications, and graft function.
- All hepatically-impaired patients entering the University of Utah hospital for a liver transplant with a Model of End-Stage Liver Disease score (MELD) >20, and viral hepatitis will be considered for enrollment. Patients must be able to give informed consent or provide a legally authorized representative.
- In addition, all conventional brain dead donors within the local organ procurement organizations jurisdiction (Intermountain Donor Services) not donating organs to the hepatically-impaired patients already enrolled in the study will be eligible for enrollment.
Guidelines for Ineligibility:
- All patients under the age of 18
- Patients will be excluded if they are less than 18 years of age, have a MELD <20, do not have viral hepatitis, are incarcerated, or are currently being treated for an active fungal infection.
- Donation after cardiac death (DCD) donors will not be enrolled.
- Donors incarcerated at the time of death will not be enrolled in the study
- In addition, liver recipients with medical contraindications to undergoing a liver biopsy will not be enrolled into the trial
- Patients with known hypersensitivity to anidulafungin, or any components of Eraxis (anidulafungin) will not be enrolled in the trial.
- Patients with medical contraindications to taking Eraxis will not be enrolled in the trial.
How long does it run?
It is anticipated that this study will run for 2.5 years. This is conditional upon the number of donor organs received.
Location(s) of clinical trial
University of Utah Hospital
Salt Lake City, Utah, United States, 84105
Principal Investigator: Jason Schwartz, M.D., University of Utah
Status: Open Enrollment
Name, Phone, Email
Contact: Jason Schwartz, M.D., 801-585-2708
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