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.

Recruiting now

Conditions studied: Children Under 3 Months of Age With Fever

In brief

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.

Key facts

Study ID: NCT06618989
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 180
Starts: 2025-02-24
Expected to finish: 2027-09-07
Last updated by the study team: 2026-04-22

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Children aged between 7 and 90 days
Visiting the emergency department with fever (Temperature greater than or equal to 38° measured rectally in the emergency department or reported by parents) OR whose fever is detected during the emergency department visit (Temperature greater than or equal to 38° measured rectally in the emergency department)
Consent signed by one of the two parents/guardians

You may not qualify if…

Weight less than 2,500 grams
Chronic illness (heart failure...)
Known immune deficiency
Congenital anomaly significantly modifying the probability of bacterial infection (pulmonary malformation, esophageal atresia...)
Antibiotic therapy in the previous 48 hours
Clinically evident source of fever: skin infection, joint infection, etc.
Parents or guardians unable to understand French
Non-affiliation with a social security scheme (including AME)

Where it is running

Sorbonne University, pediatric emergency department, Trousseau hospital — Paris, France, France (enrolling)
hospitalpediatric emergency department, Trousseau hospital — Paris, France

Full record on ClinicalTrials.gov

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