| Title: |
Effectiveness of biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection: the BATCH RCT |
| Authors: |
Waldron, Cherry Ann; Pallmann, Philip; Schoenbuchner, Simon; Harris, Debbie; Brookes-Howell, Lucy; Mateus, Céu; Bernatoniene, Jolanta; Cathie, Katrina; Faust, Saul N.; Henley, Josie; Hinds, Lucy; Hood, Kerry; Huang, Chao; Jones, Sarah; Kotecha, Sarah; Milosevic, Sarah; Nabwera, Helen; Patel, Sanjay; Paulus, Stéphane; Powell, Colin V.E.; Preston, Jenny; Xiang, Huasheng; Thomas-Jones, Emma; Carrol, Enitan D.; Whitbread, Jenny; Owens, Daniel; Pond, Jenny; Cook, Amber; Oliver, Zoe; Douglas, Claire; Jordan, Zoe; Hawkins, Rachael; Evans, Judith; Clarkstone, Sam; Maboshe, Waku; Goddard, Mark; Channon, Sue; Prout, Hayley; Smallman, Kim |
| Publication Year: |
2025 |
| Collection: |
University of Southampton: e-Prints Soton |
| Description: |
Background: procalcitonin is a biomarker specific for bacterial infection, with a more rapid response than other commonly used biomarkers, such as C-reactive protein, but it is not routinely used in the National Health Service. Objective: to determine if using a procalcitonin-guided algorithm may safely reduce duration of antibiotic therapy compared to standard of care in hospitalised children with suspected or confirmed infection. Design: a pragmatic, multicentre, open-label, parallel two-arm, individually randomised controlled trial with internal pilot phase, qualitative study and health economic evaluations. Setting: paediatric wards or paediatric intensive care units within children’s hospitals (n = 6) and district general hospitals (n = 9) in the United Kingdom. Participants: children aged between 72 hours and 18 years admitted to hospital and being treated with intravenous antibiotics for suspected or confirmed bacterial infection. Interventions: procalcitonin-guided algorithm versus usual standard care alone. Main outcome measures: coprimary outcomes were duration of intravenous antibiotic use and a composite safety measure. Results: between 11 June 2018 and 12 October 2022, 1949 children were recruited: 977 to the procalcitonin group [427 female (43.7%), 550 male (56.3%)], and 972 to the usual care group [478 female (49.2%), 494 male (50.8%)]. Duration of intravenous antibiotics was not significantly different between the procalcitonin group (median 96.0 hours) and the usual care group (median 99.7 hours) [hazard ratio = 0.96 (0.87, 1.05)], and the procalcitonin-guided algorithm was non-inferior to usual care [risk difference = −0.81% (95% confidence interval upper bound 1.11%)]. At clinical review, a procalcitonin result was available for 81.8% of the time, which was considered as part of clinical decisionmaking 66.6% of the time, and the algorithm was adhered to 57.2% of the time. Incremental cost-effectiveness ratio per duration of intravenous antibiotics hour avoided from bootstrapped samples was ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://eprints.soton.ac.uk/503305/1/3047895.pdf; Waldron, Cherry Ann, Pallmann, Philip, Schoenbuchner, Simon, Harris, Debbie, Brookes-Howell, Lucy, Mateus, Céu, Bernatoniene, Jolanta, Cathie, Katrina, Faust, Saul N., Henley, Josie, Hinds, Lucy, Hood, Kerry, Huang, Chao, Jones, Sarah, Kotecha, Sarah, Milosevic, Sarah, Nabwera, Helen, Patel, Sanjay, Paulus, Stéphane, Powell, Colin V.E., Preston, Jenny, Xiang, Huasheng, Thomas-Jones, Emma and Carrol, Enitan D. , et al. and the BATCH trial team (2025) Effectiveness of biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection: the BATCH RCT. Health Technology Assessment, 29 (16). (doi:10.3310/MBVA3675 ). |
| Availability: |
https://eprints.soton.ac.uk/503305/; https://eprints.soton.ac.uk/503305/1/3047895.pdf |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.FB6BE1C1 |
| Database: |
BASE |