NCT06155266: CYTOBACT

Combination of Leukocyte Cell Surface Biomarkers Measured by Cytometry, to Differentiate Bacterial From Viral Infections in Emergency Department: a Multicentric Cohort for the Validation of Diagnostic Performances

Recruiting now Last updated 13 January 2025

What this trial tests

trial testing 2 additional whole blood samples of 6mL each will be taken in Bacterial and Viral Infections in 500 participants. Currently enrolling.

Timeline

14 May 2024

Primary endpoint
14 August 2025

14 August 2025

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	500
Start date	14 May 2024
Primary completion	14 August 2025
Estimated completion	14 August 2025
Sites	3 locations across France

Drugs / interventions tested

• 2 additional whole blood samples of 6mL each will be taken

Conditions studied

• Bacterial and Viral Infections — all drugs for Bacterial and Viral Infections →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Bacterial and Viral Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The characterization of the bacterial or viral etiology of an infectious event is required for both isolation decisions and rationale use of antibiotics. In emergency room (ER), the direct identification of the causal pathogen is rarely available in real-time. Alternative is the identification of the host-response to either a bacterial or viral infection. One of this host-response is the expression of peripheral leukocytes cell surface markers, measured by flow cytometry. Investigators and others have reported the high diagnostic performances of combination of cell surface biomarkers to differentiate bacterial from viral infection. The CYTOBACT study aims to confirm on a 500 patients multicentric cohort (200 having already been collected during another study: SEPTIMET), the best combinations for this diagnostic issue.

The study will be conducted in 3 emergency departments of APHP hospitals network in Paris, France. Patients with a suspicion of infection will be proposed to participate. No intervention will be introduced during the routine care in the (ER) which will be let at the discretion of the treating emergency physician. During the routine blood sampling in the ER, an additional 30 ml volume of whole blood will be collected, centrifugated, aliquoted and stored at -80°C for further measurement of the expression of a panel of cell surface markers. The participants will be followed up during their hospitalization (if any) and no longer than 28 days. Clinical data at admission, usual blood tests and all microbiological investigations performed during the hospital stay will be recorded into an electronic case record form (eCRF). Based on all those recorded data (excepted the results of flow cytometry for cell surface biomarkers) 2 independent adjudicators will qualify the infectious episode into bacterial,viral or no infection, and (if any) into infection, sepsis or septic shock (according to Sepsis 3.0 definitions).

Using different "machine learning" statistical tools, all the combination of the cell surface biomarkers will be tested to select those with the highest performance to differentiate bacterial from viral infection.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Challenges in early detection and prognostication of sepsis: new approaches from the emergency department and intensive care unit.
   Lafon T, Weingart M, Vaidie J, Calfee CS, et al · · 2026 · PMID 42005923 · DOI 10.1016/j.eclinm.2026.103864