The diagnostic accuracy of presepsin for late-onset neonatal sepsis: a multicenter prospective cohort study.

Abstract

Background: Antibiotic overtreatment in infants is a significant problem, due to lack of accurate diagnostic tools for late-onset neonatal sepsis (LONS). We aimed to investigate the diagnostic accuracy of presepsin for LONS at initial suspicion.

Methods: In this multicenter prospective observational cohort study, we consecutively included all term and preterm infants who started on antibiotics empirically for a nosocomial LONS suspicion. Presepsin concentrations were determined at initial LONS suspicion before antibiotic initiation (t = 0), and 12 and 24 h afterwards. Diagnostic accuracy measures for LONS were calculated.

Results: A total of 63 episodes of suspected LONS (32 classified as LONS, including 23 culture-positive and 9 culture-negative episodes) in 50 infants were included. Presepsin concentrations were significantly higher in LONS cases compared with non-LONS at all time-points. The AUC for all LONS cases at t = 0 was 0.77 (95% CI 0.66-0.89) and 0.80 (95% CI 0.67-0.92) for culture-positive LONS cases only.

Conclusion: Presepsin seems to have insufficient accuracy as single biomarker to serve as a biomarker for ruling out LONS in infants suspected of LONS. Future larger studies are warranted to validate our findings and to investigate the clinical impact of presepsin, in combination with other biomarkers, as diagnostic tool to facilitate decision-making regarding the initiation of antibiotics, thereby supporting antibiotic stewardship.

Impact: Presepsin seems to have insufficient accuracy as single biomarker for the decision to treat or not at initial suspicion of late-onset neonatal sepsis. This is the first prospective observational cohort study on the diagnostic accuracy of presepsin for late-onset neonatal sepsis consecutively recruiting all infants suspected of late-onset neonatal sepsis, minimizing bias. Future larger studies are warranted to investigate the clinical impact of presepsin in facilitating decision-making regarding the initiation of antibiotics in infants, thereby supporting antibiotic stewardship.