Presepsin Guidance Reduces the Duration of Antibiotic Treatment in Patients with Sepsis: A Multicenter, Prospective Cohort Trial

Abstract Background: Long-term use of antibiotics for septic patients leads to antibiotic resistance. This study aimed at assessing the benefit and safety of an emerging biomarker presepsin on guiding antibiotic courses for patients with sepsis. Methods: In this multicenter prospective cohort trial, patients were assigned to the presepsin or control groups. In the presepsin group, antibiotics were ceased based on predefined cut-off ranges of presepsin concentrations. The control group stopped antibiotics according to international guidelines. The primary endpoints were the number of days without antibiotics within 28 days (superiority analysis) and mortality at 28 and 90 days (non-inferiority analysis). The margin of non-inferiority was 10%.Results: Overall, 656 out of an initial 708 patients were eligible and assigned to the presepsin group (n=327) or the control group (n=329). Patients in the presepsin group had significantly more days without antibiotics than those in the control group (14.54 days [SD 9.01] vs 11.01 days [SD 7.73]; absolute difference 3.64 days, p =0.000). Mortality in the presepsin group was non-inferior to that in the control group at days 28 (17.7% vs 18.2%; absolute difference -0∙5%, 90% CI -5.4 to 4.4) and 90 (19.9% vs 19.5%; 0.4%, -4.7 to 5.5). Patients in the presepsin group had a significantly shorter mean length of stay in the hospital and lower hospitalization costs than control subjects.Conclusions: Presepsin guidance reduces the duration of antibiotic treatment in patients with sepsis without increasing mortality. Trial registration: ChiCTR, ChiCTR1900024391. Registered 9 July 2019. Retrospectively registered.