An Open-label Study of APX001 for Treatment of Patients With Candidemia/Invasive Candidiasis Caus… (NCT04148287) | Clinical Trial Compass
CompletedPhase 2
An Open-label Study of APX001 for Treatment of Patients With Candidemia/Invasive Candidiasis Caused by Candida Auris
South Africa9 participantsStarted 2019-12-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 aspa…
What they're measuring
1
Percentage of Participants With Treatment Success at End of Study Treatment (EOST) as Determined by Data Review Committee (DRC)
Timeframe: EOST: any day from Day 1 up to maximum of Day 42