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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56538
Enrollment
300
Registered
2024-01-22
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cold Respiratory tract infection

Interventions

None listed

Sponsors

Levels Diagnostics
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)