The Performance of the Mologic Biomarker Panel in Infection

March 27, 2018 updated by: Mologic Ltd

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe infection from:

  • The Emergency Department
  • Critical Care Unit
  • Patients undergoing major surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The Emergency Department

The study aims to evaluate the test in this environment as a potential diagnostic. All patients will be screened using the electronic patient management system within the ED.

A single sample of approximately 20ml of blood, will be obtained at the same time as a clinically indicated blood culture (triggered by clinician concern for infection). The sample will be processed as described in the laboratory manual, aliquoted and frozen for future batch analysis. This analysis will include:

  • The Mologic Biomarker Panel
  • PCT
  • CRP
  • Other inflammatory markers or pathogen detection that may augment the panels accuracy

All conventional standard of care testing will be done at the study site as part of the enrolled subject's routine clinical care.
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.
Critical Care Unit

Two patient populations admitted to the CCU will be approached for inclusion into the study:

  • Patients being managed for potential infection
  • Patients having undergone elective major surgery and admitted to the CCU as part of their care pathway. These patients will act as controls as the majority show signs and symptoms of inflammation but rarely develop an infection.

Patients with potential infection: UCLH Critical Care Unit has approximately 1000 emergency admissions per year. Complicated infection (sepsis or septic shock) being the commonest underlying reason for admission.
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.
Patients undergoing major surgery
UCLH Critical Care admits approximately 1000 patients per year following major elective surgery. These patients frequently exhibit the features of SIRS but the incidence of infection/sepsis is low (approximately 5%) and very rare in the first 3 days' post-surgery. This group is to be studied as a negative control group to ensure the Mologic Biomarker Panel is able to detect the difference between the similar inflammatory phenotypes developed through infection and surgical trauma.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers and results from routine clinical testing for infection
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mologic Ltd

Collaborators

University College London Hospitals
Innovate UK

Investigators

  • Principal Investigator: David Brealey, PhD MRCP FRCA, University College London Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2017

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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