An observational study in Children Under 3 Months of Age With Fever, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 2 sites in France. Open to participants aged 7 Days to 90 Days. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's planned enrollment of 180 is below the median of 408 across 140 observational studies indexed under Fever.
Browse Fever studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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All infants aged between 7 and 90 days presenting to emergency departments with fever.
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Exclusion Criteria:
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.
Diagnostic performance of a combination of leukocyte cell surface markers for identifying IBS in febrile infants under 3 months of age presenting to emergency departments.
Diagnostic performance (sensitivity and specificity) of the best performing combination of cell surface markers for identifying BSI in febrile infants under 3 months of age presenting to emergency departments.
Time frame: At inclusion (D0)
Plan to share: Yes — The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l\'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Access criteria: Researchers who provide a methodologically sound proposal.
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