SepsisNCT03217552
The Performance of the Mologic Biomarker Panel in Infection
An observational study of Sepsis and Infection, run by Mologic Ltd at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Mologic Biomarker Panel
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2017to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe infection from: * The Emergency Department * Critical Care Unit * Patients undergoing major surgery
Who may be able to join
- ≥ 18 years old
- Investigated for potential infection (the clinical need for a blood culture)
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London, NW1 2BU
Jung Ryu, SRN, jung.ryu@nhs.net
About this study
Official title: 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.
Read more
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
- Being tested
- Mologic Biomarker Panel
- Medical subject headings
- Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mologic Biomarker PanelDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Mologic Biomarker Panel | |
| 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. Receives: Diagnostic Test: Mologic Biomarker Panel | |
| 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. Receives: Diagnostic Test: Mologic Biomarker Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start26 Nov 2017
- Primary completionApr 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mologic Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College London Hospitals, Innovate UK
- Responsible party
- Sponsor
- Investigators
- David Brealey, PhD MRCP FRCA, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217552
- Sponsor's protocol ID
- CN010
- Status last verified
- Mar 2018
- First submitted
- 12 Jul 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate the Diagnostic and Predictive Accuracy of the Mologic Biomarker Panel in Patientsrnwith Severe Infection
- ClinicalTrials.gov ID
- NCT03217552
- Acronym / sponsor ID
- CN010
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mologic LtdIndustry (pharma, biotech, devices)
- Collaborators
- University College London Hospitals, Innovate UK
- Study start
- 26 Nov 2017 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Emergency Department | – | Diagnostic Test: Mologic Biomarker PanelThe 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 | – | Diagnostic Test: Mologic Biomarker PanelTwo 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 | – | Diagnostic Test: Mologic Biomarker PanelUCLH 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe infection from: * The Emergency Department * Critical Care Unit * Patients undergoing major surgery
Key inclusion criteria (2 listed)
- ≥ 18 years old
- Investigated for potential infection (the clinical need for a blood culture)
Key exclusion criteria (5 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mologic Biomarker PanelIn 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. | Diagnostic test | Critical Care Unit, Patients undergoing major surgery, The Emergency Department |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Brealey, PhD MRCP FRCA principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Infection, run by Mologic Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chris Dunston, PhD (0044 (0)1234 780020, Chris.Dunston@mologic.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers and results from routine clinical testing for infection (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.