CandiSep
Trial question
What is the role of (1,3)-β-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
65.0% male
N = 342
342 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=173 (1,3)-β-D-glucan guidance (receipt of antifungals if at least one of two consecutive (1,3)-β-D-glucan samples taken during the first two study days ≥ 80 pg/mL).
N=169 standard care (receipt of targeted antifungal therapy driven by culture results).
Primary outcome
Death at day 28
33.7%
30.5%
33.7 %
25.3 %
16.9 %
8.4 %
0.0 %
(1,3)-beta-D-glucan
guidance
Standard
care
No significant
difference ↔
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).
Significantly shorter 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)-β-D-glucan guidance was not superior to standard care with respect to death at day 28.
Reference
Frank Bloos, Jürgen Held, Stefan Kluge et al. (1 → 3)-β-D-Glucan-guided antifungal therapy in adults with sepsis: the CandiSep randomized clinical trial. Intensive Care Med. 2022 Jul;48(7):865-875.
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