A groundbreaking UK study led by the University of Liverpool has examined whether an additional blood test called procalcitonin (PCT) could safely shorten the time children spend on intravenous (IV) antibiotics in hospitals.
Despite promising previous analysis, the study, funded by the National Institute for Health and Care Research (NIHR), found that using the PCT biomarker to guide treatment decisions did not reduce antibiotic duration when compared to usual care.
The study, published today in the Lancet Child & Adolescent Health, is part of the 'Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection' (BATCH) trial. BATCH is a national research trial to tackle antibiotic overuse in hospitalised children and reduce the spread of antimicrobial resistance (AMR).
Antibiotic overuse is a key driver of AMR, one of the world's greatest public health challenges. Infections caused by resistant bacteria lead to longer hospital stays, higher healthcare costs, and increased mortality. Children are especially vulnerable, and smarter use of antibiotics is essential to protect their future health.
This study, conducted across 15 hospitals, enrolled nearly 2,000 children aged between 72 hours and 18 years with suspected bacterial infections.
The researchers found that adding the PCT test to routine care did not reduce the duration of IV antibiotic use. The test was safe but costlier than standard methods, and healthcare teams faced challenges integrating it into their decision-making processes.
The study comes after a systematic review and cost-effectiveness analysis conducted by NICE in 2015 evaluated PCT testing to guide antibiotic therapy for the treatment of sepsis, and recommended further studies to adequately assess the effectiveness of adding PCT algorithms to guide antibiotic treatment in hospitalised adults and children with suspected or confirmed serious bacterial infection.
The results highlight that introducing new tools like PCT tests alone isn't enough. Effective use requires:
- Robust Antimicrobial Stewardship (AMS) programmes: Many hospitals already use AMS programmes to ensure antibiotics are prescribed responsibly, reducing unnecessary use.
- Training and education for Clinicians: Familiarity with new tests and confidence in interpreting results are crucial for success.
- Implementation research: Future studies should identify barriers and facilitators to implementation to optimise fidelity of the intervention.
- Behaviour Change: Better understanding of the complex interactions influencing whether/how/why clinicians act on information from diagnostic tests to make antibiotic prescribing decisions will improve trial intervention fidelity and facilitate implementation and adoption of tests shown to be effective.
The findings emphasise the importance of continuing to invest in AMS programmes and public health campaigns to reduce antibiotic misuse. The researchers note that although PCT-guided treatment didn't provide clear benefits in this trial, it could still play a role in specific situations with further refinement. As the UK progresses its Five-Year Antimicrobial Resistance Strategy, this research provides valuable insights into the challenges of implementing new diagnostic tests in hospitals.
Chief investigator the University of Liverpool's Professor Enitan Carrol said: "We are pleased to have completed this large multi-centre trial in hospitalised children. Whilst the study did not demonstrate benefit from the additional procalcitonin test, there is important learning for future biomarker-guided trials in the NHS.
"The BATCH study was a pragmatic trial evaluating if the intervention works under real-world conditions where clinicians do not have to adhere to diagnostic algorithms about antibiotic discontinuation. Adherence to the algorithm was low in our study, and there were challenges in integrating the test into routine clinical workflows. The study highlights the importance of including behaviour change and implementation frameworks into pragmatic trial designs."
Dr Emma Thomas-Jones, Principal Research Fellow and Deputy Director of Infection, Inflammation & Immunity Trials at the Cardiff Centre for Trials Research, said: "Research is vital to improving the management of serious bacterial infections, like sepsis. On behalf of the team at the Centre for Trial Research, It has been a pleasure working with Professor Carrol on this important trial, and it is testament to the multi-disciplinary team involved in delivering these results, which will make a real difference, providing clear evidence on the use of procalcitonin as a biomarker in guiding clinical decision making about antibiotic discontinuation in children with serious bacterial infections."
The BATCH trial was conducted by leading UK universities and hospitals including the University of Liverpool, Liverpool School of Tropical Medicine, Alder Hey Children's NHS Foundation Trust, the Centre for Trials Research, Cardiff University, the University of Southampton and Lancaster University, Sheffield Children's NHS Foundation Trust, Oxford University Hospitals NHS Foundation, Bristol Royal Hospital for Children, University Hospital Southampton NHS Foundation Trust and Hull York Medical School.
It is the largest trial of its kind to evaluate PCT-guided antibiotic treatment in children.
Click here to read the full paper.
