Clinical trial NCT06618989: 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.
Official title: 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. ( CYTOFEB )
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Children Under 3 Months of Age With Fever
Keywords: fever
diagnostic
severe bacterial infections
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Pasteur Institute
name: Centre de recherche en épidémiologie et bio statistiques
name: Pitié Salpêtrière Biological Resource Center
name: Centre d'immunologie et des maladies infectieuses
First posted: 2024-10-01
Enrollment: 180
Sex: ALL
Minimum age (years): 7
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants aged between 7 and 90 days presenting to emergency departments with fever.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: 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.
timeFrame: At inclusion (D0)
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: hospitalpediatric emergency department, Trousseau hospital
city: Paris
country: France
facility: Sorbonne University, pediatric emergency department, Trousseau hospital
Study officials:
affiliation: Sorbonne University, hospitalpediatric emergency department, Trousseau hospital
name: Maxime Enault, MD
role: PRINCIPAL_INVESTIGATOR
References: