Fluorescent Leukocytes as a Marker of Early Sepsis/Severity

NCT07585942 | Not Yet Recruiting

• 2 other identifiers: RC26_0024CE-2026-37
• Study Type: observational
• Target: 492
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Septic Shock; Disseminated Intravascular Coagulation (DIC)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Sepsis; Disseminated Intravascular Coagulation; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Thrombophilia; Shock

Central Study Contacts

Julie HELMS, Professor

CONTACT

+33 3 69 55 13 69; julie.helms@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 14, 2026
• Study Start: May 12, 2026
• Primary Completion (Estimated): November 12, 2027
• Study Completion (Estimated): December 12, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

FR (1)