The Performance of the Mologic Biomarker Panel in Infection

Sponsor
Mologic Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03217552
Collaborator
University College London Hospitals (Other), Innovate UK (Other)
600
1
19.1
31.4

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Mologic Biomarker Panel

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An Observational Study to Evaluate the Diagnostic and Predictive Accuracy of the Mologic Biomarker Panel in Patientsrnwith Severe Infection
Actual Study Start Date :
Nov 26, 2017
Anticipated Primary Completion Date :
Apr 1, 2019
Anticipated Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Biomarkers and results from routine clinical testing for infection [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University College London Hospital London United Kingdom NW1 2BU

Sponsors and Collaborators

  • Mologic Ltd
  • University College London Hospitals
  • Innovate UK

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mologic Ltd
ClinicalTrials.gov Identifier:
NCT03217552
Other Study ID Numbers:
  • CN010
First Posted:
Jul 14, 2017
Last Update Posted:
Mar 29, 2018
Last Verified:
Mar 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2018