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NCT Number: 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.

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.

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Key information

Age range

7 day–90 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Sorbonne University, pediatric emergency department, Trousseau hospital, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood sampling and follow-up call

Other

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.

Primary outcomes

  1. 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.

    Time frame: At inclusion (D0)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maxime Enault, MD

CONTACT

[email protected]

+33 171738297

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Centre d'immunologie et des maladies infectieuses
  • Centre de recherche en épidémiologie et bio statistiques
  • Groupe Hospitalier Pitie-Salpetriere
  • Pasteur Institute

Registry information

Official study 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 )

Acronym: CYTOFEB

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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