an open-label study of apx001 for treatment of patients with candidemia/invasive candidiasis caused by candida auris

Conditions: Candidemia; Invasive Candidiases; Candida Infection

Summary: this is a multicenter, open-label, single arm study to evaluate the efficacy and safety of apx001 for the treatment of candidemia and/or invasive candidiasis caused by c. auris in patients aged 18 years and over with limited antifungal treatment options.

this is a multicenter, open-label, non-comparative, single arm study to evaluate the efficacy and safety of apx001 for the treatment of candidemia and/or invasive candidiasis caused by c. auris in patients aged 18 years and over with limited antifungal treatment options. the study drug treatment period will be up to a maximum of 42 days (inclusive of the loading dose \[study day 1\]). there will be a follow up period of 4 weeks (+4 days) after eost. the total duration of participation in the study is up to approximately 10.5 weeks (inclusive of the screening period \[168 hours prior to baseline\]).

Eligibility criteria:
inclusion criteria: * limited or no treatment options due to resistance, contraindication, intolerance or lack of clinical response to standard of care antifungal therapy, as advocated by the relevant regional/country treatment guidelines * established mycological and clinical diagnosis of candidemia and/or invasive candidiasis caused by candida auris * able to have pre-existing intravascular catheters removed and replaced (if necessary) * females of childbearing potential with male partners, and males with female partner(s) of childbearing potential, must agree to use 2 forms of highly effective contraception throughout the duration of the study and for 90 days following the last study drug administration. females of childbearing potential must have a negative urine pregnancy test within 96 hours prior study entry. * wiling to participate in the study, willing to give written informed consent, and willing to comply with the study restrictions; where permitted by local regulations, written informed consent from a legal authorized representative (lar) will be obtained for patients who are unable to give consent exclusion criteria: * life expectancy of less than 7 days in the opinion of the investigator * human immunodeficiency virus-infected patients who are receiving antiretroviral therapy that are moderate to strong inducers of cyp3a4, or who have detectable viremia, or who have had an active opportunistic infection within 6 months prior * alanine aminotransferase or aspartate aminotransferase greater than or equal to 5 times the upper limit of normal * total bilirubin greater than 3 time the upper limit of normal, unless isolated hyperbilirubinemia or due to documented gilbert's disease * pregnant or lactating female patient * inappropriate fungal infection source control * investigational drug administered within 30 days prior to dosing or five half-lives whichever is longer * diagnosis of deep-seated candida-related infections causing hardware associated septic arthritis, osteomyelitis, endocarditis, myocarditis, hepatosplenic candidiasis, or a central nervous system infection or site of infection that would require antifungal therapy to exceed the maximal duration of study drug treatment