Plasma presepsin level can differentiate between bacterial and viral infections in young infants with fever of unknown origin
ID
Source
Brief title
Health condition
Fever of unknown origin
Sponsors and support
Intervention
Outcome measures
Primary outcome
Plasma presepsin level in different patient groups at the timepoint presentation at emergency department
Secondary outcome
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. All secondary outcomes will be measured at the timepoints presentation at emergency department.
Background summary
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.
Study objective
Plasma presepsin level can differentiate between bacterial and viral infections in young infants with fever of unknown origin
Study design
1
Inclusion criteria
- Age under 3 months - Temperature >38,0 C (measured by parents or at emergency department, tympanic or rectally) - Fever of unknown origin - Visiting emergency department from home - Submitted to blood sampling for infection as part of routine care, i.e. blood culture and/or infection parameters - Informed consent of parent(s) or legal guardian(s)
Exclusion criteria
None
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9293 |
| CCMO | NL74009.029.20 |
| OMON | NL-OMON54911 |