Biomarker signature discovery study to determine acute bacterial respiratory tract infection.

• Conditions: cold; Respiratory tract infection; 10024970

• Registration Number: NL-OMON56538
• Lead Sponsor: evels Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

RTI group (250 patients) -Mentally competent & adult, bacterial or viral
respiratory tract infection) Controlgroup (50 patients): -Mentally competent &
adult, patients without clinical signs of a respiratory tract infection

Exclusion Criteria

RTI group: Undefined (unable to determine and identify the pathogenic origin)
respiratory tract infection.
Control group: fever or other symptoms known to RTIs within 14 days prior to
inclusion.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters<br /><br>The current experiment has been designed to identify biomarker signatures with<br /><br>discriminative differences as to the expression within the blood plasma of<br /><br>patients. The primary study parameter is the concentration of those specific<br /><br>biomarkers resulting in a concentration of protein per mL blood plasma. This<br /><br>will then be used in our machine learning analysis to form biomarker profiles<br /><br>capable of determining an acute bacterial respiratory tract infection. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters<br /><br>After the performance analysis of the biomarkers to determine an acute<br /><br>bacterial respiratory tract infection, the performance of these markers will be<br /><br>tested against a number of known covariants. These are the following:<br /><br>1. Analysis of the performance of the biomarkers to identify disease severity<br /><br>(e.g. PSI/PORT scoring in CAP subpopulation or by CURB65/qSOFA categorizing;<br /><br>2. Analysis of the performance of the biomarkers in selected pathogen groups;<br /><br>3. Analysis of the performance of the biomarkers across multiple disease<br /><br>backgrounds;<br /><br>4. Analysis of the performance of the biomarkers comparing patients who are<br /><br>pre-treated with antibiotics versus non pre-treated patients.</p><br>