Fluorescent Leukocytes as a Marker of Early Sepsis/Severity

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.

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Key information

Conditions

Sepsis Blood Coagulation Disorders Disseminated Intravascular Coagulation Disseminated Intravascular Coagulation (DIC) Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome Thrombophilia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Strasbourg, 67098, France

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

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

Time frame: 3 days
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

Study contacts

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

Julie HELMS, Professor

CONTACT

[email protected]

+33 3 69 55 13 69

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: FLAMES

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 14, 2026
Registry last updated: May 14, 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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Completed