Doctors in the UK have identified promising evidence for the effectiveness of an early and rapid diagnostic test for sepsis.
Sepsis is a serious complication arising from infection, which can swiftly progress to life-threatening organ failure and is responsible for around 48 000 deaths annually in England. Recent findings, published today in The Lancet Respiratory Medicine, demonstrate that an accessible clinical decision-making tool significantly reduced mortality, with the greatest benefit seen among patients from the most deprived communities. However, the study also showed no difference in the speed of intravenous antibiotic initiation, despite initial expectations.
Diagnosing sepsis in emergency departments remains difficult, as many non-infectious illnesses can mimic its symptoms and there is currently no definitive diagnostic test. This uncertainty contributes to both over- and underdiagnosis. In both situations, delayed treatment can cost lives, while rapid antibiotics are required for those with confirmed sepsis some patients may be treated for sepsis unnecessarily, contributing to the urgent global issue of antimicrobial resistance (AMR). At the same time, misdiagnosis can lead to a failure to correctly identify and treat the actual underlying condition.
A procalcitonin‑guided algorithm is a clinical decision‑making tool that uses levels of the biomarker procalcitonin (PCT) to help guide antibiotic therapy in patients with suspected bacterial infections. However, it is not currently recommended for use in emergency settings because previous research has been inconsistent.
To address this gap, the research team conducted a large, controlled trial which randomised 7667 patients who presented to emergency departments with suspected sepsis. The study tested whether adding the rapid procalcitonin-guided algorithm testing to current clinical practice could help clinicians recognise sepsis more accurately, reduce unnecessary antibiotic prescribing, and maintain at least the same level of patient safety, measured by overall mortality.
The study shows:
- There was a 17% relative reduction in mortality from 16.6% to 13.6% which means for every 1000 patient treated as suspected sepsis, 31 lives are potentially saved.
- Patients from the most deprived areas experienced the greatest mortality benefit. Existing research explores inequality in sepsis outcomes, and this latest research may help to overcome identified systemic biases.
- Importantly, the trial found that regardless of whether patients were treated with the procalcitonin‑guided algorithm or received standard care, there was no difference in how quickly intravenous antibiotics were started. Although the research team had anticipated that the algorithm might improve early antibiotic initiation, the trial showed it did not – a key finding, given this was one of the co‑primary outcomes.
Co-chief investigator, Dr Stacy Todd, Consultant in Infectious Diseases and General Medicine, NHS University Hospitals of Liverpool Group, said: “The evidence supports the value of early and rapid diagnostics and indicates a need for further biomarker and algorithm development. Uptake of procalcitonin-guided care into health systems will now depend on greater understanding of the mechanism of effect, further health economic evaluations, and robust implementation frameworks.”
Source: University of Liverpool
