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Sepsis Prognosis and Diagnosis in the Emergency Department (SPEED)

Sepsis Clinical Trial

Official title:
Sepsis Prognosis and Diagnosis in the Emergency Department Using a Host Response Classifier (SPEED) UK - a Multi-Centre Observational Study

Clinical Trial Summary

This study aims to evaluate the diagnostic and prognostic performance of a novel mRNA diagnostic/prognostic classifier (interprets the expression of 29 host response mRNA biomarkers) from whole blood in adult patients presenting to emergency departments (ED) with suspected infection.

Clinical Trial Description

Study measurements consists of a blood collection via venepuncture into a PAXgene® Blood RNA tube (2.5 ml) and Na-Heparin tube (4 ml) normally within 1 hour of enrolment into the study. The samples will be stored and transferred in batches from recruiting centres to a core laboratory. The expression of 29 mRNAs contained in the IMX-BVN-4/SEV-4 classifier will be analysed to determine the likelihood of bacterial and viral infection, as well as the likelihood of clinical deterioration. A nasopharyngeal swab sample will also be obtained for participants with suspected respiratory tract infection. Clinical data collection will be recorded from source data using an electronic Case Report Form (eCRF) The diagnosis of infection will be confirmed by a clinical adjudication panel blinded to the ED and hospital discharge diagnosis for each case. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05639504
Study type Observational
Source Inflammatix
Contact
Status Withdrawn
Phase
Start date December 2022
Completion date May 2023
View Details
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