MedTrace Logo

Diagnostic Performance of a Combination of Leukocyte Cell Surface Markers in Predicting the Risk of Severe Bacterial Infection in Febrile Children Under Three Months of Age in the Emergency Department: a Pilot Study.

NCT06618989 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2026-04-22

No results posted yet for this study

Summary

Fever is a frequent reason for emergency department (ED) visits in infants under 3 months of age. Although viral infections are the most common etiologies, the prevalence of severe bacterial infections (SBI) is high (10%). While in infants with SBI, establishing the diagnosis and initiating rapid intravenous antibiotic therapy is necessary, every effort should be made to avoid it in those at low risk of SBI.

Clinical examination and biomarkers are still sub-optimal for assessing the risk of SBI. As a result, the vast majority of these children receive inpatient intravenous antibiotic therapy.

Flow cytometry is a technique for measuring the expression of biomarkers on the cell surface of leukocytes in response to infection. A French team has identified a combination of some fifteen leukocyte cell surface markers that perform excellently in discriminating between bacterial and viral infections in a population of adults presenting to the emergency department with a suspected infection. However, there are no similar studies in children.

The objective of the study is to assess the diagnostic performance of a combination of biomarkers on the cell surface of leukocytes in discriminating between bacterial and viral infection. Infants less than 3 months of age, visiting the ED for fever will have an extra blood sample in order to measure those biomarkers. The performance of those biomarkers to identify SBI will be assessed.

Conditions

  • Children Under 3 Months of Age With Fever

Interventions

OTHER

Blood sampling and follow-up call

An additional 1.5 mL of blood will be collected at the time of the child care in the pediatric emergency department. In addition, a telephone call for patient follow-up (unless still hospitalized) will be done.

Sponsors & Collaborators

  • Pasteur Institute

    collaborator UNKNOWN

  • Centre de recherche en épidémiologie et bio statistiques

    collaborator UNKNOWN

  • Pitié Salpêtrière Biological Resource Center

    collaborator UNKNOWN

  • Centre d'immunologie et des maladies infectieuses

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Maxime Enault, MD · Sorbonne University, hospitalpediatric emergency department, Trousseau hospital

Eligibility

Min Age
7 Days
Max Age
90 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2027-08-24
Completion
2027-09-07

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06618989 on ClinicalTrials.gov