NCT03217552

The Performance of the Mologic Biomarker Panel in Infection

An Observational Study to Evaluate the Diagnostic and Predictive Accuracy of the Mologic Biomarker Panel in Patientsrnwith Severe Infection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Mologic Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single center, observational, cohort study of patients to determine whether the Mologic Biomarker Panel can identify patients with infection from those without, including those with other reasons for inflammation (e.g. post-operative). It will also assess whether it has the potential to judge the severity of illness, prognosticate outcome and guide antibiotic therapy. The aim is to recruit patients who are "representative" of patients with suspected sepsis, uncomplicated infection, or non-infection related critical illness that require critical care intervention and assessment. This study is observational and will not alter patient management or the standard of care. The results from the investigational Mologic Biomarker Panel and associated research assays will not be provided to treating clinicians, or used in any manner to affect patient care. The study will take place over approximately an 18-month period and it is anticipated that approximately 600 patients will be collectively enrolled. The study aims to recruit patients from three environments within UCLH: * The Emergency Department. * Critical Care Unit * Patients undergoing major surgery

Conditions

• Sepsis
• Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Mologic Biomarker Panel	In brief the proposed biomarkers will be measured in the laboratory of Mologic . These will initially be performed using standard lab assays (Enzyme Linked Immunosorbent Assays, ELISA). Biomarkers that show promise will then be mounted on a novel lateral flow device (under development), that could ultimately be deployed at the patients bedside.

Timeline

• Start date: 2017-11-26
• Primary completion: 2019-04-01
• Completion: 2019-07-01
• First posted: 2017-07-14
• Last updated: 2018-03-29

Locations

1 site across 1 country: United Kingdom