PRONTO v1.0
Research type
Research Study
Full title
Procalcitonin and NEWS2 evaluation for Timely identification of Sepsis and Optimal use of antibiotics in the Emergency Department
IRAS ID
268723
Contact name
Neil French
Contact email
Sponsor organisation
University of Liverpool
ISRCTN Number
ISRCTN54006056
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Summary of Research
Sepsis is a common, potentially life-threatening complication of infection. The optimal treatment for sepsis includes early recognition, prompt antibiotics and fluids into a vein (intravenous/IV). Currently, clinicians assess severity in patients in the Emergency Department with a scoring system based on simple to measure observations: the National Early Warning Score (NEWS2). NEWS2 helps clinicians identify the sickest patients. It is not specific and tends to over-diagnose sepsis leading to over prescribing of antibiotics and promoting antimicrobial resistance. It is the best we have and currently used in over 70% of English hospitals. Adults with suspected sepsis fall into one of three categories: a) those looking ill needing urgent IV antibiotics and fluids within 1 hour, b) those that are unwell, but will not come to harm if IV antibiotics are not administered within 1 hour, allowing time for further assessment prior to starting antibiotics within 3 hours, c) those not critically unwell who may or may not need IV antibiotics. Procalcitonin (PCT), a blood test not widely used in the NHS, helps to identify bacterial infection. The National Institute for Health and Care Excellence (NICE) recommended further research on PCT testing in emergency departments for guiding antibiotic use in people with suspected sepsis.PRONTO is a study funded by the National Institute for Health Research (NIHR) run by University of Liverpool and Cardiff trials unit looking to improve assessment of patients with suspected sepsis in the emergency department using a 20 minute test. We want to reduce the amount of unnecessary broad spectrum antibiotics used with a minimum of no change in mortality.
Summary of Results
Sepsis is a common, potentially life-threatening complication of infection. Currently, clinicians assess patients in the Emergency Department (ED) with a scoring system based on simple to measure observations: the National Early Warning Score (NEWS2). NEWS2 helps doctors identify the sickest patients. It is not specific and tends to over-diagnose sepsis leading to over prescribing of antibiotics, promoting antimicrobial resistance. Procalcitonin (PCT) is a blood test that helps to identify bacterial infection and is not widely used in the NHS. The National Institute for Health and Care Excellence (NICE) recommended further research on PCT testing in EDs to see if it is useful in reducing unnecessary antibiotic use in people with suspected sepsis. The PRONTO trial was funded by the National Institute for health and Care Research and was sponsored by the University of Liverpool. The trial team had a patient and public member with lived experience of sepsis who gave input into trial design and trial documentation and supported all aspects of the trial throughout. PRONTO was carried out in 22 NHS hospital EDs across England and Wales. Adults with suspected sepsis who came to the ED either received standard care or PCT-supported care. For those who received PCT-supported care, a bedside test was performed alongside NEWS2 assessment. Depending on the result of the PCT plus the NEWS2, patients received intravenous (IV) antibiotics and fluids. Analysis of the data helped to understand how well clinicians followed the recommendations, how easy the additional test was to use, and its clinical and cost effectiveness. Health Care Professionals and patients were interviewed to assess their experiences of care and taking part in the trial. The trial found that making the PCT-guided assessment available to doctors in EDs did not reduce the number of people who were given IV antibiotics, but it did significantly reduce numbers of deaths within the 90 day follow up period. This means that the reduction in deaths was not linked to a reduction in antibiotic prescribing but more appropriate care which may have included better targeting of antibiotic prescribing, earlier recognition and better management of sepsis, and improved management of non-infectious conditions. The intervention was generally welcomed by end-users, in particular helping to strengthen and provide confidence for clinical decisions rather than categorical changes in management. The cost-effectiveness of the intervention was assessed as not/borderline, although this assessment is strongly affected by the relatively short follow up in this study. Future research is needed to look at health outcomes over a longer period of time.REC name
Wales REC 2
REC reference
20/WA/0058
Date of REC Opinion
22 Jul 2020
REC opinion
Further Information Favourable Opinion