Using blood markers to predict severe bacterial infections in young children with fever
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 )
Run by Assistance Publique - Hôpitaux de Paris · NCT06618989 · Data updated 2026-11-12
This study is testing if certain blood markers can help doctors tell if young children with fever have serious bacterial infections, to improve diagnosis and reduce unnecessary antibiotic use.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 7 Days to 90 Days |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris, France and 1 other locations) |
| Status | Recruiting |
| Started | February 24, 2025 |
| Main results expected | August 24, 2027 |
| Study ends | September 7, 2027 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT06618989 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants aged between 7 and 90 days who present to the emergency department with a fever.
✕Probably not a fit
Patients who have chronic illnesses, known immune deficiencies, or are currently on antibiotic therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study aims to evaluate the diagnostic performance of a combination of leukocyte cell surface markers in predicting the risk of severe bacterial infections (SBI) in infants under three months of age presenting with fever in the emergency department. By utilizing flow cytometry, the study will analyze blood samples to identify specific biomarkers that can help differentiate between bacterial and viral infections. The goal is to improve the accuracy of diagnosis and reduce unnecessary antibiotic treatments in low-risk patients. The study will involve blood sampling and follow-up calls to monitor outcomes.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and reduced unnecessary antibiotic use in young children with fever.
How similar studies have gone: Previous studies have shown promising results using similar biomarker approaches in adults, but this specific application in infants is novel.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Sorbonne University, pediatric emergency department, Trousseau hospital
Paris, France, France Recruiting -
hospitalpediatric emergency department, Trousseau hospital
Paris, France Not yet recruiting
Study contacts
- Principal investigator: Maxime Enault, MD — Sorbonne University, hospitalpediatric emergency department, Trousseau hospital
- Study coordinator: Maxime Enault, MD
- Email: maxime.enault@aphp.fr
- Phone: +33 171738297
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.