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Biomarker test could significantly reduce antibiotic use in sepsis, finds trial

A major UK patient trial of a new biomarker testing protocol for sepsis, led by University of Manchester researchers, has shown it is possible to safely stop antibiotic treatment earlier than current care.

The duration reduction of around 10% could provide significant cost savings to health systems, limit unwanted drug side-effects, reduce overtreatment and reduce the development of antimicrobial resistance in individuals, across communities and internationally.

The study was commissioned and funded by the National Institute for Health and Care Research (NIHR), and its leading partners were The University of Manchester, Northern Care Alliance NHS Foundation Trust and Warwick Medical School’s Clinical Trials Unit, who specialise in research in emergency and critical care.

Chief investigator Paul Dark, Professor of Critical Care at the University of Manchester will present the findings to a global online audience at the prestigiousCritical Care Reviews Meeting this week (10/12/24), where it will be scrutinised and debated by some of the world’s leading experts in the field.

The research team are also to publish their peer reviewed findings in JAMA- one of the world’s leading medical journals today

According to the charity Sepsis Research FEAT, around 50,000 people are estimated to die of sepsis in the UK each year, which develops when the body's immune system overreacts to an infection and starts attacking its own tissues and organs.

Accounting for 100,000 hospital admissions a year in the UK, it is estimated that there are 49 million cases and 1 million deaths a year globally.

Recognising sepsis and starting antibiotics early are crucial but until now the recommended duration of such treatment has been uncertain.

The only available option recommended for doctors currently is to use their judgement to decide when to discontinue the potent broad spectrum antibiotics, usually reserved to treat the condition.

The new decision support system is based on a simple blood test, carried out daily and available in most NHS hospital laboratories.

It tests for levels of a circulating protein called procalcitonin (PCT), which is produced as part of the body’s immune system responses to bacterial infections.

Higher levels indicate a greater likelihood of bacterial infection and sepsis, with subsequent falling levels indicating favourable responses to treatments

A computer automated response, based on the PCT levels from the blood test, advises doctors whether to discontinue antibiotic treatment or not. A further commonly measured circulating inflammation protein (C-reactive protein or CRP) was also tested.

The randomized controlled trial was based at 41 intensive care units across the UK, involving 2,760 adults from January 2018 to June 2024.

It compared 918 patients on a PCT protocol with 924 patients on a C-reactive protein (CRP) and 918 patients on current standard care.

Clinicians responsible for managing patients received daily standardized written advice on either standard care or on PCT or CRP biomarker-guided antibiotic discontinuation.

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