The Performance of the Mologic Biomarker Panel in Infection
An Observational Study to Evaluate the Diagnostic and Predictive Accuracy of the Mologic Biomarker Panel in Patientsrnwith Severe Infection
1 other identifier
observational
600
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedStudy Start
First participant enrolled
November 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedMarch 29, 2018
March 1, 2018
1.3 years
July 12, 2017
March 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
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.
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.
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.
Interventions
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.
Eligibility Criteria
Patients with severe infection from: * The Emergency Department * Critical Care Unit * Patients undergoing major surgery
You may qualify if:
- ≥ 18 years old
- Investigated for potential infection (the clinical need for a blood culture)
You may not qualify if:
- \<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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mologic Ltdlead
- University College London Hospitalscollaborator
- Innovate UKcollaborator
Study Sites (1)
University College London Hospital
London, NW1 2BU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Brealey, PhD MRCP FRCA
University College London Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2017
First Posted
July 14, 2017
Study Start
November 26, 2017
Primary Completion
April 1, 2019
Study Completion
July 1, 2019
Last Updated
March 29, 2018
Record last verified: 2018-03