Using blood markers to tell apart bacterial and viral infections in emergency departments
Combination of Leukocyte Cell Surface Biomarkers Measured by Cytometry, to Differentiate Bacterial From Viral Infections in Emergency Department: a Multicentric Cohort for the Validation of Diagnostic Performances
This study is testing if certain blood markers can help doctors quickly tell the difference between bacterial and viral infections in patients who come to the emergency room.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT06155266 on ClinicalTrials.gov |
What this trial studies
This study aims to differentiate between bacterial and viral infections in patients attending emergency departments by analyzing specific cell surface biomarkers on leukocytes using flow cytometry. It will involve a multicentric cohort of 500 patients, with data collected from routine blood samples and clinical information recorded in an electronic case report form (eCRF). The study will evaluate the diagnostic performance of various combinations of these biomarkers against a reference standard established by an independent expert committee. The goal is to improve the accuracy of infection diagnosis in real-time, which is crucial for appropriate treatment decisions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who present with a suspicion of infection in the emergency department.
Not a fit: Patients who are pregnant, lack social insurance, or are incarcerated will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of infections, potentially reducing unnecessary antibiotic use and improving patient outcomes.
How similar studies have performed: Previous studies have shown promising results in using cell surface biomarkers to differentiate between bacterial and viral infections, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18 year-old * Attending one of the participant ED from Monday to Friday between 8:30 am to 3:00 pm * With a suspicion of infection (defined by either a measured temperature above 38°C or any microbiology diagnostic test ordered during the routine care) * Having blood sampling during routine care * Informed and having expressed his/her non-opposition to participate Exclusion Criteria: * \- Pregnancy * No social insurance * Prisoners
Where this trial is running
Paris and 2 other locations
- Service des urgences, Lariboisière — Paris, France (Not_yet_recruiting)
- Service des urgences, Saint-Antoine — Paris, France (Not_yet_recruiting)
- Service des urgences, Pitié Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: laetitia Velly, MD
- Email: laetitia.velly@aphp.fr
- Phone: (33)7 82 28 94 91
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.