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

PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal use of antibiotics in the Emergency department.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54006056

Enrollment

7676

Registered

2019-12-19

Start date

2020-11-01

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspected sepsis Infections and Infestations Septicaemia

Interventions

A procalcitonin (PCT) point-of-care test (testing equipment provided by ThermoFisher) used in combination with NEWS2 assessment of adult patients with suspected sepsis in emergency departments, using

Eligibility

Sex/Gender

All

Age

16 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients =16 years presenting to the ED with suspected sepsis

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Co-primary outcomes: 1. IV antibiotics initiation at 3 hours (superiority endpoint) 2. Mortality at 28 days (non-inferiority endpoint)	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 03/05/2022: 1. Time until initiation of IV antibiotic therapy: time of antibiotic initiation, antibiotic type, dose and duration are taken at admission and daily as required 2. Late IV antibiotic initiation: antibiotics commenced after 3 hours, time of IV antibiotic initiation, dose and duration are taken as required) 3. Number of days on IV antibiotics: type, dose and duration of antibiotic taken during admission and total over the first 28 days as required 4. Number of days on any antibiotic: type, dose, and duration of antibiotic taken during admission and total over the first 28 days s required 5. Number of days on broad-spectrum antibiotics (IV and oral), defined by the number of days on an Access group of antibiotics as defined by the WHO AWaRe Classification Database (type, dose and duration of broad-spectrum antibiotic during admission and total over the first 28 days as required) 6. ICU admission: date and details of admission to ICU at any point during admission 7. Length of ICU stay: number of days in ICU taken from medical notes 8. Length of hospital stay: number of days of admission taken from medical notes 9. Adverse antibiotic outcomes: date and type of adverse events taken from medical notes as required 10. Readmission to hospital within 90 days: ICU re-admissions post-discharge date 11. Mortality within 90 days: date and description of death and time until death in days from admission 12. Health utility measured using EQ-5D/5L at 28 and 90 days 13. Health resource usage: patient reported medical costs and resource use collected at 28 and 90 days 14. Feasibility of implementing PCT testing alongside NEWS2 scoring in EDs assessed using qualitative interviews with HCPs throughout the duration of the trial 15. Acceptability of implementing PCT testing alongside NEWS2 scoring in EDs, to patients, carers and clinicians, assessed using qualitative interviews with HCPs throughout the duration of the trial 16. Total a	—

Measure

Time frame

Current secondary outcome measures as of 03/05/2022: 1. Time until initiation of IV antibiotic therapy: time of antibiotic initiation, antibiotic type, dose and duration are taken at admission and daily as required 2. Late IV antibiotic initiation: antibiotics commenced after 3 hours, time of IV antibiotic initiation, dose and duration are taken as required) 3. Number of days on IV antibiotics: type, dose and duration of antibiotic taken during admission and total over the first 28 days as required 4. Number of days on any antibiotic: type, dose, and duration of antibiotic taken during admission and total over the first 28 days s required 5. Number of days on broad-spectrum antibiotics (IV and oral), defined by the number of days on an Access group of antibiotics as defined by the WHO AWaRe Classification Database (type, dose and duration of broad-spectrum antibiotic during admission and total over the first 28 days as required) 6. ICU admission: date and details of admission to ICU at any point during admission 7. Length of ICU stay: number of days in ICU taken from medical notes 8. Length of hospital stay: number of days of admission taken from medical notes 9. Adverse antibiotic outcomes: date and type of adverse events taken from medical notes as required 10. Readmission to hospital within 90 days: ICU re-admissions post-discharge date 11. Mortality within 90 days: date and description of death and time until death in days from admission 12. Health utility measured using EQ-5D/5L at 28 and 90 days 13. Health resource usage: patient reported medical costs and resource use collected at 28 and 90 days 14. Feasibility of implementing PCT testing alongside NEWS2 scoring in EDs assessed using qualitative interviews with HCPs throughout the duration of the trial 15. Acceptability of implementing PCT testing alongside NEWS2 scoring in EDs, to patients, carers and clinicians, assessed using qualitative interviews with HCPs throughout the duration of the trial 16. Total a

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Countries

England, United Kingdom

Contacts

Public ContactJoanne Euden

eudenj@cardiff.ac.uk+44 (0)2922510771

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026