Presepsin in young infants with fever

Rationale: Rapid and accurate biomarkers for the detection of bacterial infections are warranted in young infants presenting at the emergency department. Delay in diagnosis may lead to significant morbidity and even mortality. Current diagnostic strategies for the detection of bacterial infections are either time-consuming (at least 12 hours for e.g. blood cultures and infection markers) or suboptimal in its accuracy (infection markers have a sensitivity around 80%). Presepsin proved to be an accurate biomarker for the detection of sepsis in adults and neonates and is therefore promising in the subgroup of infants under 3 months presenting with fever of unknown origin.
Objective: To compare differences in plasma presepsin levels between young infants with a bacterial and a viral infection. Secondary objectives are to determine a cut-off value for bacterial infection; to assess the diagnostic accuracy of presepsin in the detection of bacterial infections in young infants presenting with fever of unknown origin, also as compared to currently used infection parameters; to divide young infants in which no pathogen is found into a group with high and low prespsin levels and compare differences in clinical characteristics between these two groups, in order to identify a clinical pattern associated with probable bacterial infection.
Study design: Prospective observational cohort study
Study population: Young infants (<3 months of age) presenting at the emergency department with fever of unknown origin and undergoing routine blood sampling will be eligible for study participation. For this study, 230 patients will be included.
Main study parameters/endpoints: see objectives, in short: the plasma presepsin level, a cut-off value of plasma presepsin level for bacterial infection, the diagnostic accuracy of presepsin in detection of bacterial infection, a clinical pattern associated with probable bacterial infection based on high and low presepsin levels.

Plasma presepsin level can differentiate between bacterial and viral infections in young infants with fever of unknown origin

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