The Performance of the Mologic Biomarker Panel in Infection

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03217552
• Other study ID #: CN010
• Status: Recruiting
• First received: July 12, 2017
• Last updated: March 27, 2018
• Start date: November 26, 2017
• Est. completion date: July 2019

Study information

• Verified date: March 2018
• Source: Mologic Ltd
• Contact: Chris Dunston, PhD
• Phone: 0044 (0)1234 780020
• Email: Chris.Dunston[@]mologic.co.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old

• Investigated for potential infection (the clinical need for a blood culture)

Exclusion Criteria:

• <18 years old

• Severe anaemia (<60g/dl) and contra-indication to transfusion

• Unable to gain consent or agreement

• Treated with palliative intent

• Blood culture indicated for screening or monitoring

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Sepsis

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Mologic Ltd	Innovate UK, University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers and results from routine clinical testing for infection	Research assay will be used to test for the investigational Mologic biomarker panel and these results will be assessed using the results obtained from conventional testing used to identify infection (such as white cell count and CRP), in order to find a clinical association with the mologic biomarkers and patients with infections.	18 months