WithdrawnNot Applicable

Sepsis Prognosis and Diagnosis in the Emergency Department (SPEED)

Stopped: Study never started, change in company focus on US

0Started 2022-12

Plain-language summary

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.

Who can participate

Age range16 Years

SexALL

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Inclusion criteria

✓. Clinically suspected infection of any aetiology as the reason for attendance; AND
✓. NEWS2 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:
✕. 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
✕. Prisoners or those in police custody
✕. Patients who permanently lack the capacity to give informed consent
✕. Previously enrolled in SPEED UK study

What they're measuring

Primary Outcome 1

Timeframe: Admission

Primary Outcome 2

Timeframe: Within 7 days after admission

Trial details

NCT IDNCT05639504

SponsorInflammatix

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-04

View on ClinicalTrials.gov More Respiratory Tract Infections trials