Procalcitonin-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection in the UK (BATCH): a pragmatic, multicentre, open-label, two-arm, individually randomised, controlled trial
Authors: Cherry-Ann Waldron, Philip Pallmann, Simon Schoenbuchner, Debbie Harris, Lucy Brookes-Howell, Céu Mateus, Jolanta Bernatoniene, Katrina Cathie, Saul N Faust, Lucy Hinds, Kerenza Hood, Chao Huang, Sarah Jones, Sarah Kotecha, Helen M Nabwera, Sanjay Patel, Stéphane C Paulus, Colin V E Powell, Jenny Preston, Huasheng Xiang, Emma Thomas-Jones, Enitan D Carrol, Enitan D Carrol, Rachael Hawkins, Emma Thomas-Jones, Cherry-Ann Waldron, Sarah Kotecha, Waku Maboshe, Debbie Harris, Mark Goddard, Philip Pallmann, Simon Schoenbuchner, Lucy Brookes-Howell, Josie Henley, Sarah Milosevic, Hayley Prout, Kim Smallman, Sue Channon, Sam Clarkstone, Judith Evans, Kerry Hood, Colin VE Powell, Céu Mateus, Huasheng Xiang, Saul N Faust, Chao Huang, Sarah Jones, Helen Nabwera, Sarah Dee, Lisa Duncan, Rachael Hawkins, Joanne Johnston, Caroline Lambert, Phoebe Mususka, Sarah Siner, Jenny Whitbread, Jolanta Bernatoniene, Alvin Schadenberg, Tracey Bingham, Helen Boal, Victoria Carter, Evangeline Clayton, Karen Coy, Mia Critchley, Sandra Dymond, Anu Goenka, Zoe Jordan, Maryam Hamdollah-Zadeh, David Hopgood, Anna Laskey, Melanie Marsh, Marion Roderick, Elyna Seymour, Stefania Vergnano, Katrina Cathie, Saul N Faust, Sanjay Patel, Daniel Owens, Leonora Beed, Victoria Bingham, Donna Bowens, Susan Burke, Sophie Cadnam, Amber Cook, Emily Cornish, Jessica Cutler, Ruth Ensom, Nichola Etherington, Aimee Griffiths, Anna Hardy, Jane Johnston, Rebecca Mayes, Jenni McCorkell, Lisa Mcgailey, Sarah McKay, Christie Mellish, Alastair Munro, Caitlin Oxford, Jenny Pond, Catherine Postlewaite, Gabrielle Price, Genevieve Roberts, Sally Salter, Laura Sparks, Andrea Taylor, Philippa Thomas, Emy Van Der Harg, Nina Vanner, Charlotte Wilson, Stéphane Paulus, Claire Douglas, Rebecca Harmer, Sarah Hopton, Danielle Miller, Zoe Oliver, Imogen Stamford, Clare Taylor, Lucy Hinds, John Beachill, Carolyn Clark, Stuart Gormley, Rachel Harrison, Kim Redfern, Janet Shackleton, Martin Edwards, Jennifer Muller, Louise Yendle, Helen Dallow, Susie Holt, Murthy Saladi, Caroline Burchett, Sarah De Beger, Maggie Nyirenda, Lisa Capozzi, Melanie Ekani, Emma Gardiner, Paddy McMaster, Rachel Newport, Grainne O'Connor, Jenny Philbin, Chloe Rishton, Zainab Sarwar, Chloe Scott, Anita Solanki, Prakash Kamath, Rachel Newport, Grainne O'Connor, Beena Padmakumar, Jenny Philbin, Chloe Rishton, Zainab Sarwar, Chloe Scott, John-Paul Williamson, Simon Birch, Marta Czekaj, Andrew Gribbin, Andrew Collinson, Chris Black, Charlotte Barker-Kirby, Ruth Bowen, Kim Lindsey, Kate McGraw Allen, Jo Webber, Sian Ludman, Emma Chamberlain, Heather Palfrey, Megan Purchall, Suzanne Wilkins, Stacy Wilson, Ifeanyichukwu Okike, Melanie Hayman, Laura Miketa, Gisela Robinson, Coral Smith, Vanessa Unsworth, Mark P Tighe, Oana Langston, Sue Power, Amy Roff, Erika Rojas-Jimenz
Journal: The Lancet Child & Adolescent Health (2025)

SummaryBackgroundProcalcitonin is a rapid response biomarker specific for bacterial infection, which is not routinely used in the UK National Health Service. We aimed to assess whether using a procalcitonin-guided algorithm would safely reduce the duration of antibiotic therapy compared with usual care, in which C-reactive protein is the commonly used biomarker.MethodsThe BATCH trial was a pragmatic, multicentre, open-label, parallel, two-arm, individually randomised, controlled trial conducted in 15 hospitals in England and Wales. Children aged 72 h to 18 years who were admitted to hospital and were being treated with intravenous antibiotics for suspected or confirmed bacterial infection and who were expected to remain on intravenous antibiotics for more than 48 h were enrolled. Participants were randomly assigned (1:1) to receive either current clinical management alone (usual care group) or clinical management with the addition of a procalcitonin test guided algorithm (procalcitonin group). Participants were randomly assigned by minimisation, with site and age group (0–6 months, 6 months to 2 years, 2–5 years, and older than 5 years) as minimisation factors and a random element to reduce predictability. Participants were randomly assigned remotely using a secure 24 h web-based randomisation programme. The coprimary outcomes were duration of intravenous antibiotic use, assessed for superiority, and a composite safety measure, assessed for non-inferiority (non-inferiority margin 5%). The primary analysis sample for each coprimary endpoint included all randomly assigned participants with available outcome data. This trial is registered with the International Standard Randomised Controlled Trial Number registry, ISRCTN11369832.FindingsBetween June 11, 2018, and Oct 12, 2022, 15 282 children were screened for eligibility, 1949 of whom were randomly assigned to receive procalcitonin-guided antibiotic therapy (n=977) or usual care (n=972). The median intravenous antibiotic duration was 96·0 h (IQR 59·5–155·5) in the procalcitonin group and 99·7 h (61·2–153·8) in the usual care group (hazard ratio 0·96 [95% CI 0·87–1·05]). 78 (9%) of 917 participants in the procalcitonin group and 85 (9%) of 904 participants in the usual care group had at least one event covered by the composite safety outcome measure (estimated adjusted risk difference –0·81% [95% CI upper bound 1·11]).InterpretationIn children with suspected or confirmed bacterial infection admitted to hospitals in England and Wales for intravenous antibiotic treatment of at least 48 h, the introduction of a procalcitonin-guided algorithm did not reduce duration of intravenous antibiotics treatment and is non-inferior to usual care for safety outcomes. Therefore, evidence does not support the use of procalcitonin-guided algorithms where robust effective paediatric antibiotic stewardship programmes are established.FundingNational Institute for Health and Care Research.