BATCH

Biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection trial.

The ‘Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection’ (BATCH) trial is a national research trial to tackle antibiotic overuse in hospitalised children and reduce the spread of antimicrobial resistance. It is coordinated by the Centre for Trials Research, Cardiff University and led by the University of Liverpool and Alder Hey Children’s NHS Foundation Trust.

Currently, when children are hospitalised with bacterial infections there are no evidence-based guidelines on how long to treat the infection for, and doctors may treat for longer than is necessary, leading to overuse of antibiotics, which contributes to antimicrobial resistance.

The BATCH trial will use a personalised approach to safely reduce antibiotic duration in children hospitalised with bacterial infection, through the use of a specific blood test called Procalcitonin.

Most hospitals in the NHS use a blood test called C-Reactive Protein (CRP) to monitor response to antibiotics, but it is not specific for bacterial infection and shows a delayed response. The Procalcitonin test is specific for bacterial infection and responds more quickly than CRP, but is not routinely used in the NHS. Studies done mainly in adults shows that using Procalcitonin to guide clinicians may reduce the amount of antibiotics used, reduce hospital stay, and is not associated with adverse effects such as hospital re-admission, incomplete treatment of infections, relapse or death.

A recent guideline from the National Institute for Health and Care Excellence (NICE) recommends further research on Procalcitonin testing to guide antibiotic use in children.

The trial is being led by Professor of Paediatric Infection Enitan Carrol, from the University of Liverpool’s Institute of Infection and Global Health and Alder Hey Children's NHS Foundation Trust, and aims to ascertain whether this personalised approach can improve patient safety and quality of care, reduce the spread of antimicrobial resistance and reduce time in hospital.

Professor Carrol said: “Our work on diagnostic and prognostic biomarkers of infection in children with bacterial infection over the past five years, has generated evidence suggesting that a personalised approach using serial measurements of biomarkers, could help to tackle antibiotic overuse in hospitalised children. We are delighted to be leading on this national study which will help to definitively answer that question.”

In total, 1942 children (under 18 years of age) who are hospitalised with suspected or confirmed bacterial infection will be recruited from Paediatric wards or Paediatric Intensive Care Units (PICUs). Those who are randomised to the intervention arm will have procalcitonin test(s) in addition to their standard usual care. Children randomised to the control arm will receive their standard usual care.

The trial comprises an internal pilot and will be conducted across ten sites in the UK. The trial will last for 3 years.

Expected publication date is 31 July 2023.