A point of care test to aid in diagnosis of suspected sepsis and optimal use of antibiotics in adults presenting to A & E

Phase 3

• Conditions: Suspected sepsis; Infections and Infestations; Septicaemia

• Registration Number: ISRCTN54006056
• Lead Sponsor: niversity of Liverpool

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35697438/ (added 15/06/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-19
• Last Update Posted: 20 November 2023
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 7676

Inclusion Criteria

Patients =16 years presenting to the ED with suspected sepsis

Exclusion Criteria

1. Currently on intravenous antibiotics
2. Current use of any chemotherapy agent associated with myeloablation/suppression
3. History of solid organ transplantation, allogeneic bone marrow or stem cell transplantation within 3 months prior to consent
4. Patients known to require urgent surgical intervention (within the course of current admission)
5. Presence of an advance directive to withhold life-sustaining treatment (patients not wishing to receive Cardiopulmonary Resuscitation (CPR) may qualify provided they receive all other resuscitative measures e.g. respiratory support, fluid resuscitation)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Co-primary outcomes:<br> 1. IV antibiotics initiation at 3 hours (superiority endpoint)<br> 2. Mortality at 28 days (non-inferiority endpoint)<br>