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The Performance of the Mologic Biomarker Panel in Infection

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ClinicalTrials.gov Identifier: NCT03217552
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
University College London Hospitals
Innovate UK
Information provided by (Responsible Party):
Mologic Ltd

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
Sepsis Infection Diagnostic Test: Mologic Biomarker Panel

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Study Type : Observational
Estimated 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 : November 26, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with severe infection from:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217552


Contacts
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Contact: Chris Dunston, PhD 0044 (0)1234 780020 Chris.Dunston@mologic.co.uk
Contact: John Wilkins, PhD 0044 (0)1234 780020 John.Wilkins@mologic.co.uk

Locations
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United Kingdom
University College London Hospital Recruiting
London, United Kingdom, NW1 2BU
Contact: Jung Ryu, SRN       jung.ryu@nhs.net   
Sponsors and Collaborators
Mologic Ltd
University College London Hospitals
Innovate UK
Investigators
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Principal Investigator: David Brealey, PhD MRCP FRCA University College London Hospital

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Responsible Party: Mologic Ltd
ClinicalTrials.gov Identifier: NCT03217552     History of Changes
Other Study ID Numbers: CN010
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases