Sepsis Prognosis and Diagnosis in the Emergency Department (SPEED)

Inflammatix

Status: Withdrawn

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

Treatments: Diagnostic Test: IMX-BVN-4 and IMX-SEV-4

Study type: Observational

Funder types: Industry

Identifiers

NCT05639504

INF-25

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

NEWS2 score of 2-4

Description:

Bio-sample collection

Treatment:

Diagnostic Test: IMX-BVN-4 and IMX-SEV-4

NEWS2 score of 5-6

Description:

Bio-sample collection

Treatment:

Diagnostic Test: IMX-BVN-4 and IMX-SEV-4

NEWS2 score of ≥7

Description:

Bio-sample collection

Treatment:

Diagnostic Test: IMX-BVN-4 and IMX-SEV-4