"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
18 years or older
Drug study, Phase 3
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of SCY-078 in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.
Who can participate
Must have a documented eligible invasive and/or severe fungal disease that is
refractory or intolerant to Standard-of-Care treatment
Be able to tolerate medication orally or through a nasogastric (NG) tube or
percutaneous endoscopic gastrostomy (PEG) tube
Be able to understand and sign a written informed consent form (ICF), which must be
obtained prior to treatment and any study-related procedures.
Be able to understand and sign a consent or authorization form which shall permit the
use, disclosure and transfer of the subject's personal health information. (e.g., in
the U.S. HIPAA Authorization form).
Be able to understand and follow all study-related procedures including study drug
Agree to use a medically acceptable method of contraception while receiving
An invasive fungal disease with CNS involvement.
Subject has an inappropriately controlled fungal disease source (e.g., persistent
catheters that cannot be removed and are likely the source of infection).
Subject is hemodynamically unstable, requiring vasopressor medication for blood
A life expectancy < 30 days.
Subject with abnormal liver test parameters: aspartate aminotransferase (AST), alanine
aminotransferase (ALT) >10 x the upper limit of normal (ULN), and/or total bilirubin >
5 x ULN.
Subject is pregnant or lactating.
Subject has used an investigational drug within 30 days prior to the baseline visit.