Sepsis Prognosis and Diagnosis in the Emergency Department (SPEED)

Launched by INFLAMMATIX · Nov 28, 2022

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ClinConnect Summary

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 infecti...

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Eligibility criteria

• 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