6/28/23, 12:25 AM CandiSep Pathway Feedback Search Clinical Topics Home Studies CandiSep CandiSep Disease Disease Invasive candidiasis Sepsis and septic shock Trial question What is the role of (1,3)- -D-glucan-guided antifungal therapy in patients with sepsis at high risk for invasive candidiasis? Study design Multi-center Open label RCT Population Characteristics of study participants 35.0% female N = 339 65.0% male 339 patients (120 female, 222 male) Inclusion criteria: adult patients with sepsis at high risk for invasive Candida infection Key exclusion criteria: proven invasive Candida infection; systemic antifungal therapy prior to inclusion; liver cirrhosis of Child-Pugh class c; recent treatment with immunoglobulins; immunosuppression Interventions N=172 (1,3)- -D-glucan guidance (receipt of antifungals if at least one of two consecutive (1,3)- -D-glucan samples taken during the first two study days 80 pg/mL) N=167 standard care (receipt of targeted antifungal therapy driven by culture results) Primary outcome Death at day 28 33.7 33 7 % 30 5 https://web.pathway.md/studies/recyd4AWnZJ8GVlvA 1/2 6/28/23, 12:25 AM 33.7 % CandiSep Pathway 30.5 25.3 % 16.9 % 8.4 % No significant difference 0.0 % (1,3)-beta-D-glucan guidance Standard care No significant difference in death at day 28 (33.7% vs. 30.5%; RR 1.1, 95% CI 0.8 to 1.51) Secondary outcomes No significant difference in death in the hospital (34.5% vs. 35.9%; RR 0.96, 96% CI 0.71 to 1.29) Significant increase in antifungal-free survival at day 28 (30.2% vs. 52.1%; RR 2.97, 95% CI 2.1 to 4.2) Significant decrease in time to antifungal therapy (1.1 days vs. 4.4 days; AD -3.3 days, 95% CI -5.81 to -0.79) Conclusion In adult patients with sepsis at high risk for invasive Candida infection, (1,3)- -D-glucan guidance was not superior to standard care with respect to death at day 28. Reference Frank Bloos, J rgen Held, Stefan Kluge et al. (1 3)- -D-Glucan-guided antifungal therapy in adults with sepsis: the CandiSep randomized clinical trial. Intensive Care Med. 2022 Jul;48(7):865-875. Open reference URL https://web.pathway.md/studies/recyd4AWnZJ8GVlvA 2/2