Sepsis Prognosis and Diagnosis in the Emergency Department (SPEED)

Inflammatix

Overview

This study aims to evaluate the diagnostic and prognostic performance of a novel mRNA diagnostic/prognostic classifier (interprets the expression of 29 host response mRNA biomarkers) from whole blood in adult patients presenting to emergency departments (ED) with suspected infection.

Study measurements consists of a blood collection via venepuncture into a PAXgene® Blood RNA tube (2.5 ml) and Na-Heparin tube (4 ml) normally within 1 hour of enrolment into the study. The samples will be stored and transferred in batches from recruiting centres to a core laboratory. The expression of 29 mRNAs contained in the IMX-BVN-4/SEV-4 classifier will be analysed to determine the likelihood of bacterial and viral infection, as well as the likelihood of clinical deterioration. A nasopharyngeal swab sample will also be obtained for participants with suspected respiratory tract infection. Clinical data collection will be recorded from source data using an electronic Case Report Form (eCRF) The diagnosis of infection will be confirmed by a clinical adjudication panel blinded to the ED and hospital discharge diagnosis for each case.

Study Type

OBSERVATIONAL

Conditions

Respiratory Tract Infections Urinary Tract Infections Intra-Abdominal Infections Skin and Soft Tissue Infection Suspected Meningitis/Encephalitis or Any Other Infection Sepsis

Interventions

IMX-BVN-4 and IMX-SEV-4DIAGNOSTIC_TEST

Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: Adult participants (16 years and older) presenting to the ED (or related assessment and treatment facilities such as SDEC or AMU) with: 1. Clinically suspected infection of any aetiology as the reason for attendance; AND 2. NEWS2 score of ≥2 (any dimension, using latest score) Exclusion Criteria: 1. Treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to the ED visit. Participants will not be excluded for use of: * Antiviral treatment for HIV infection and hepatitis B and hepatitis C * Topical antibiotics, topical antiviral or topical antifungal agents * Anti-herpes prophylaxis aiding suppression of a recuring herpes infection * Peri-operative (prophylactic) antibiotics * A single dose of antimicrobials during the present ED visit; note single dose can be considered mono- or combination therapy, wherein combination is administered as part of local Standard of Care and only one dose of each medication is administered 2. Presence of an advance directive to withhold life-sustaining treatment or a clear plan in place to that effect (ie. an explicit decision by patient/family/carer in conjunction with clinical team that active treatment beyond symptomatic relief is not appropriate). Note that patients who do not wish to receive cardiopulmonary resuscitation (CPR) but active treatment is still indicated may still qualify for entry into study 3. Prisoners or those in police custody 4. Patients who permanently lack the capacity to give informed consent 5. Previously enrolled in SPEED UK study

Outcomes

Primary Outcomes

Primary Outcome 1

Performance of the host response classifier IMX-BVN-4 to diagnose bacterial and viral infection as compared to clinical adjudication (sensitivity, specificity, likelihood ratios).

Time frame: Admission

Primary Outcome 2

Prognostic performance of IMX-SEV-4 using an endpoint of receipt of critical-level care (including requirement for admission to critical care, mechanical ventilation, vasopressors (\>12 hours), or renal replacement therapy) within 7 days (sensitivity, specificity, likelihood ratios).

Time frame: Within 7 days after admission

Secondary Outcomes

Secondary Outcome 1

Prognostic performance of IMX-SEV-4 using a composite endpoint of Receipt of critical-level care (including requirement for transfer to critical care, mechanical ventilation, vasopressors (\>12 hours), or renal replacement therapy) within 7 days, and/or 28-day in-hospital mortality (sensitivity, specificity, likelihood ratios).

Time frame: Up to 28 days after admission

Secondary Outcome 2

Diagnostic performance of the IMX-BVN-4 classifier in determining bacterial and viral infection compared with other biomarkers (procalcitonin and lactate) and clinical or laboratory findings obtained from standard of care, as compared to clinical adjudication (sensitivity, specificity, likelihood ratios).

Time frame: Admission

Secondary Outcome 3

Prognostic performance of IMX-SEV-4 for clinical deterioration (NEWS2 of 5 or higher) within 7 days (sensitivity, specificity, likelihood ratios).

Time frame: Within 7 days after admission

Data from ClinicalTrials.gov

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