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)

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 )

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.

Study Overview

• Status: Recruiting
• Conditions: Children Under 3 Months of Age With Fever
• Intervention / Treatment: Other: Blood sampling and follow-up call

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Maxime Enault, MD; Phone Number: +33 171738297; Email: maxime.enault@aphp.fr

Study Locations

• France
  • Paris, France, 75012
    • Not yet recruiting
    • hospitalpediatric emergency department, Trousseau hospital
    • Contact: Maxime Enault, MD; Phone Number: +33 171738297; Email: maxime.enault@aphp.fr
  • France
    • Paris, France, France, 75012
      • Recruiting
      • Sorbonne University, pediatric emergency department, Trousseau hospital
      • Contact: Maxime Enault, MD; Phone Number: +33 1 71 73 82 97; Email: maxime.enault@aphp.fr
      • Contact: Romain Guedj, MD; Email: romain.guedj@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All infants aged between 7 and 90 days presenting to emergency departments with fever.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At inclusion (D0)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Pasteur Institute; Centre de recherche en épidémiologie et bio statistiques; Pitié Salpêtrière Biological Resource Center; Centre d'immunologie et des maladies infectieuses
• Investigators: Principal Investigator: Maxime Enault, MD, Sorbonne University, hospitalpediatric emergency department, Trousseau hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): August 24, 2027
• Study Completion (Estimated): September 7, 2027

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: fever; diagnostic; severe bacterial infections
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Bacterial Infections and Mycoses; Body Temperature Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease; Fever; Bacterial Infections; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: APHP231307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• IPD Sharing 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
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No