Using a biomarker to diagnose infections in children
A Combinatorial Biomarker for Infection Diagnosis in Children
This study is testing a new biomarker to see if it can help doctors better diagnose respiratory infections in children and decide on the right treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 770 (estimated) |
| Ages | 5 Months and up |
| Sex | All |
| Sponsor | Universität des Saarlandes Academic / other |
| Locations | 4 sites (Berlin and 3 other locations) |
| Trial ID | NCT05971901 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a combinatorial biomarker, BV, in diagnosing respiratory tract infections and fever in children. It will compare clinical outcomes between patients with high BV scores, indicating bacterial infections, and those with low scores, indicating viral infections. The study will also assess adherence to test results and the impact on treatment decisions, including the use of antimicrobial therapy and hospitalization rates.
Who should consider this trial
Good fit: Ideal candidates include children suspected of having acute bacterial or viral infections who require a BV test during their medical evaluation.
Not a fit: Patients who do not provide informed consent or do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of infections in children, improving treatment outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using biomarkers for infection diagnosis, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suspicion of acute bacterial or viral infection * Requirement of at least one BV test during medical presentation Exclusion Criteria: * lack of informed consent
Where this trial is running
Berlin and 3 other locations
- Sana Kliniken — Berlin, Germany (Not_yet_recruiting)
- Universitätsklinikum Bonn — Bonn, Germany (Not_yet_recruiting)
- Saarland University — Homburg, Germany (Recruiting)
- Universitätsklinikum Würzburg — Würzburg, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Cihan Papan, MD — Universität des Saarlandes
- Study coordinator: Cihan Papan, MD
- Email: cihan.papan@uni-saarland.de
- Phone: +4968411623900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.