Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT05639504

Sepsis Prognosis and Diagnosis in the Emergency Department (SPEED)

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

Status
Withdrawn
Phase
—
Study type
Observational
Enrollment
0 (actual)
Sponsor
Inflammatix · Industry
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTIMX-BVN-4 and IMX-SEV-4Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection

Timeline

Start date
2022-12-01
Primary completion
2023-04-01
Completion
2023-05-01
First posted
2022-12-06
Last updated
2023-12-27

Source: ClinicalTrials.gov record NCT05639504. Inclusion in this directory is not an endorsement.