The Performance of the Mologic Biomarker Panel in Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-26

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immune Failure in Critical Therapy (INFECT) Study

NCT02186522

Sepsis Septic Shock

COMPLETED

Molecular Diagnosis and Risk Stratification of Sepsis

NCT01905033

Sepsis

UNKNOWN

Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

NCT06178822

Sepsis Septic Shock Sepsis, Severe +4 more

RECRUITING

Prognostic Interest of Leucocyte Immunophenotyping During the Acute Phase of Sepsis

NCT01995448

Sepsis With Acute Organ Dysfunction

COMPLETED

A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-response Based Diagnostic Tool for Early Detection of Severe Infections.

NCT06665542

Sepsis Acute Infection

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Mologic Biomarker Panel

Intervention Type DIAGNOSTIC_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.

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.

Mologic Biomarker Panel

Intervention Type DIAGNOSTIC_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.

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.

Mologic Biomarker Panel

Intervention Type DIAGNOSTIC_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No