Fluorescent Leukocytes as a Marker of Early Sepsis/Severity (FLAMES)

NEUTROPHIL FLUORESCENCE AS AN EARLY BIOMARKER OF SEPSIS SEVERITY IN THE EMERGENCY DEPARTMENT

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Septic Shock; Disseminated Intravascular Coagulation (DIC)

• Study Type: Observational
• Enrollment (Estimated): 492

Contacts and Locations

• Study Contact: Name: Julie HELMS, Professor; Phone Number: +33 3 69 55 13 69; Email: julie.helms@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67098
    • The University Hospitals of Strasbourg, Intensive Care Medicine Department - New Civil Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the Emergency Department and undergoing routine blood sampling will be prospectively included. The cohort aims to evaluate early biomarkers for the prediction of sepsis or septic shock within 72 hours of admission. No additional procedures or interventions beyond standard care are performed.

Description

Inclusion Criteria:

• 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
• Patient informed and has not expressed opposition

Exclusion Criteria:

• Pregnancy or breastfeeding
• Legal protection measure (guardianship, curatorship, judicial protection)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Emergency Patients; Prospective multicenter observational cohort study evaluating the prognostic value of neutrophil fluorescence parameters measured at emergency department admission using a novel hematology analyzer. Data are collected from routine blood samples and used to develop an artificial intelligence model without additional intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the association between neutrophil fluorescence, whether isolated or integrated into an AI model based on CBC results combined with the advanced multiparametric capabilities of the SthemA 801 analyzer	The primary evaluation criterion is the occurrence of sepsis or septic shock within 72 hours following admission to the Emergency Department, defined according to SEPSIS-3 by at least one of the following: Admission to intensive care, critical care, or continuous care; One or more acute organ failures, defined by a SOFA score ≥ 2 points; Need for vasopressor treatment; Blood lactate > 2 mmol/L; Death within 72 hours	3 days

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Estimated): May 12, 2026
• Primary Completion (Estimated): November 12, 2027
• Study Completion (Estimated): December 12, 2027

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Shock; Thrombophilia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Sepsis; Shock, Septic; Disseminated Intravascular Coagulation
• Other Study ID Numbers: RC26_0024; CE-2026-37 (Other Identifier: ETHICS COMMITTEE of the Faculties of Medicine, Dentistry, Pharmacy, Nursing Schools, Physiotherapy, Midwifery, and Hosp)

Drug and device information, study documents

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