Presepsin as diagnostic marker for bacterial infection in young infants with fever of unknown origi

Completed

• Conditions: bacterial infection; sepsis; 10004018

• Registration Number: NL-OMON54911
• Lead Sponsor: Medisch Centrum Alkmaar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 230

Inclusion Criteria

- Age under 3 months
- Temperature 38,0 °C or higher
- Fever of unknown origin
- Visiting emergency department from home
- Submitted to blood sampling evaluation as part of standard care, i.e. blood
culture and/or infection parameters
- Informed consent of parent(s) or legal guardian(s)

Exclusion Criteria

None

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The plasma presepsin level in infants with a bacterial or a viral infection </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- A cut-off value of plasma presepsin level for bacterial infection in young<br /><br>infants<br /><br>- The diagnostic accuracy of presepsin for bacterial infection in young<br /><br>infants, also as compared to currently used infection parameters.<br /><br>- A clinical pattern associated with probable bacterial infection, determined<br /><br>by high and low presepsin levels in young infants in which no pathogen is<br /><br>found.</p><br>