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The Performance of the Mologic Biomarker Panel in Infection

NCT03217552 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2018-03-29

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University College London Hospitals

    collaborator OTHER

  • Innovate UK

    collaborator OTHER_GOV

  • Mologic Ltd

    lead INDUSTRY

Principal Investigators

  • David Brealey, PhD MRCP FRCA · University College London Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-26
Primary Completion
2019-04-30
Completion
2019-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03217552 on ClinicalTrials.gov