BATCH Trial
Research type
Research Study
Full title
Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (The BATCH trial)
IRAS ID
235042
Contact name
Enitan Carrol
Contact email
Sponsor organisation
University of Liverpool
ISRCTN Number
ISRCTN11369832
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Sepsis defined as the body’s response to infection, and is often indistinguishable from the response to other insults like burns or surgery. Giving antibiotics promptly saves lives, but giving antibiotics to people who don’t need them, leads to overuse of antibiotics and antimicrobial resistance (AMR). Department of Health recommends that antibiotics should be given for as short a course as is safe, to prevent AMR.
Most hospitals in the NHS use a C-Reactive Protein (CRP) blood test to monitor response to infection, but it is not specific for bacterial infection and shows a delayed response to infection. Procalcitonin is a blood test which 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.
BATCH aims to assess the use of an additional PCT test in children (aged <18 years) hospitalised with suspected or confirmed bacterial infection to guide antimicrobial prescribing decisions. Children will be recruited from Paediatric wards or Paediatric Intensive Care Units (PICUs).
In children randomised to the intervention arm, a PCT test will be performed in the hospital laboratory at baseline, Day 3-5, Day 6-14 and Day 28 (if still on IV antibiotics)(aligned with normal clinical workflow and routine laboratory testing). Children in the control arm will not have a PCT test performed.
Outcome data will be recorded daily by the Research Nurse (up to and including day 28, or until discharge). Day 28 follow up will be conducted with parents via telephone/email.
The study comprises an internal pilot with 6 lead sites. Additional sites will be added as required. The study will last for 3 years.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0100
Date of REC Opinion
12 Apr 2018
REC opinion
Further Information Favourable Opinion