Eligibility

Local study conflicts

• None

Inclusion Criteria:

• Setting 1: Emergency Department or Acute Medical / Surgical Assessment Unit
• Patients with suspected infectious disease, or confirmed COVID-19 infection, or influenza
• Age ≥ 18 years
• Research samples collected in conjunction with blood culture sampling for clinical workup at presentation to ED and patients subsequently enrolled where sepsis criteria are fulfilled
• (Nb. the study has other inclusion criteria for patients in other areas of the hospital; they are not listed here)

Sepsis criteria

• Sepsis defined according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)1:
• Suspected infection
• AND
• Acute change in total Sequential Organ Failure Assessment (SOFA) score by ≥2 points
• OR
• quick Sequential Organ Failure Assessment (qSOFA) score by ≥2 points

Patients with sepsis due to community-acquired pneumonia (CAP) or faecal peritonitis (FP) will be prioritised

Diagnostic criteria for CAP include:

• Pyrexia
• Cough with sputum production
• Breathlessness
• Leukocytosis
• Radiological features of pneumonia e.g. new infiltrates
• Acquired in the community or developing within 48 hours of hospital admission

Diagnosis for FP includes:

• Inflammation of the serosal membrane lining the abdominal cavity secondary to contamination by faeces, as diagnosed at laparotomy. For each case of FP, the underlying cause is documented.
• Review and adjudication of recruited cases by two experienced clinicians will be carried out to ensure accurate diagnosis.

COVID-19 / influenza criteria:

• Confirmation of COVID-19 or influenza infection will be based on the combination of clinical suspicion e.g. travel history, contact history or relevant symptoms and a positive laboratory diagnostic test for the respective viruses.

Exclusion Criteria:

• <18 years of age
• Patient,personal or nominated consultee or healthy volunteer unwilling or unable to give written informed consent / advice or witnessed verbal consent / verbal consultee advice
• Advanced directive to withhold or withdraw life-sustaining treatment
• Admission for palliative care only
• Severe acquired immunodeficiency e.g.
• high dose steroid therapy (prednisolone or equivalent 0.5mg/kg/day for 14 days or longer (inhaled, intra-articular or topical steroids not considered))
• HIV infection
• known regular therapy with other immunosuppressive agents (e.g. azathioprine)
• neutrophil count less than 1000 mm-3 due to any cause including metastatic disease and haematological malignancies or chemotherapy, but excluding severe sepsis
• an organ or bone marrow transplant receiving immuno-suppressive therapy

If the patient is eligible:

• Gain verbal agreement in principle before proceeding. Explain:
• Taking part in research is likely to improve the quality of their care
• Risks are carefully controlled - research is safe
• Explain the uncertainty that exists with respect to treatment of their condition
• If they change their mind they can withdraw their participation at any point

Step-by-Step Guide to Recruitment:

In the working hours of the research team:

• Monday-Friday 07:30 – 18:30


• Contact the EMROx research team on:
  Mobile 0776818242
  Tel 01865 222003
  Bleep 6680

Out of hours and weekends:

• None. Patients can only be recruited during the research team's working hours.