Treatment.
infection, candidiasis
INFECTION, CANDIDIASIS, SECONDARY, ADVERSE EVENT
Participants were treated with FMGX within 12 h of study enrollment (Study Design. For participants with invasive candidiasis, maintenance dosing was to continue until there was at least 1 negative tissue culture or aspirate/fluid. For participants with a deep-seated site of infection from which a tissue culture was not obtainable, maintenance dosing was to continue until after the resolution of the attributable clinical signs of infection recorded at baseline, and as applicable, radiological improvement associated with the site of infection. BID, twice daily; EOST, end of study treatment; FMGX, fosmanogepix; IV, intravenous; PO, orally; QD, once daily.Plasma samples for pharmacokinetic (PK) analysis of FMGX and MGX levels were collected at baseline (pre-dose), twice weekly during treatment, at EOST/early termination (ET), and 2 weeks after EOST. Adverse events (AEs) were recorded from the date of informed consent through study completion, and coded (using Medical Dictionary for Regulatory Activities [MedDRA] version 22.0).The primary efficacy endpoint was the percentage of participants with DRC-assessed treatment success at EOST, defined as clearance of Secondary efficacy parameters included all-cause mortality through Day 30, and time to first negative blood culture. The DRC also assessed treatment success at 2 and 4 weeks after EOST. Investigator-assessed secondary parameters included percentage of participants with successful mycological outcomes, treatment success at EOST and 2 and 4 weeks after EOST, and the number of participants with TEAEs.