Sepsis Prognosis and Diagnosis in the Emergency Department (SPEED)

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.

Inclusion Criteria:Adult participants (16 years and older) presenting to the ED (or related assessment and treatment facilities such as SDEC or AMU) with:Clinically suspected infection of any aetiology as the reason for attendance; ANDNEWS2 score of ≥2 (any dimension, using latest score)Exclusion Criteria: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 CTopical antibiotics, topical antiviral or topical antifungal agentsAnti-herpes prophylaxis aiding suppression of a recuring herpes infectionPeri-operative (prophylactic) antibioticsA 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 administeredPresence 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 studyPrisoners or those in police custodyPatients who permanently lack the capacity to give informed consentPreviously enrolled in SPEED UK study