Fluorescent Leukocytes as a Marker of Early Sepsis/Severity

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

Sepsis is a medical emergency whose prognosis depends on the early identification of patients at risk of septic shock, but the tools available in the Emergency Department remain insufficient. Neutrophils, key players in immunothrombosis, show alterations detectable via cell fluorescence (e.g., NE-SFL), which are strongly correlated with the severity of sepsis and septic DIC. The FLAMES study will evaluate, from the time of admission to the Emergency Department, the relevance of neutrophil fluorescence as an early biomarker of severity, either alone or integrated into an AI model based on the multiparametric data from the SthemA 801, with comparison to the Sysmex XN. It aims to address an unmet clinical need: the immediate stratification of the risk of severe forms of sepsis. Hypothesis: higher initial fluorescence will identify patients at risk of organ failure, septic shock, or DIC.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Admission to the ED

Suspected or proven infection defined by the prescription of antibiotic therapy within 24 hours following admission to the ED

Collection of an EDTA blood sample as part of routine care

Disqualifiers

Pregnancy or breastfeeding

Legal protection measure (guardianship, curatorship, judicial protection)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

492 Participants
are grouped into 1 trial group