| 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 ... |
| Relation: |
https://livrepository.liverpool.ac.uk/3194642/1/HTA%20BATCH.pdf; Collapse authors list. Waldron, CA orcid:0000-0001-8465-2492 , Pallmann, P orcid:0000-0001-8274-9696 , Schoenbuchner, S orcid:0000-0003-4892-2170 , Harris, D orcid:0000-0002-7073-7724 , Brookes-Howell, L orcid:0000-0002-8263-7130 , Mateus, C orcid:0000-0001-6219-219X , Bernatoniene, J orcid:0009-0005-2941-9125 , Cathie, K orcid:0000-0001-5074-0769 , Faust, SN orcid:0000-0003-3410-7642 , Henley, J orcid:0000-0002-2709-900X et al (show 31 more authors) , Hinds, L orcid:0000-0002-5042-4368 , Hood, K orcid:0000-0002-5268-8631 , Huang, C orcid:0000-0002-3627-7218 , Jones, S, Kotecha, S orcid:0000-0001-5640-0300 , Milosevic, S orcid:0000-0003-1973-8286 , Nabwera, H orcid:0000-0003-1056-729X , Patel, S orcid:0000-0001-6329-0496 , Paulus, S orcid:0000-0002-0703-9114 , Powell, CVE orcid:0000-0001-8181-875X , Preston, J orcid:0000-0003-4800-234X , Xiang, H orcid:0000-0002-5515-001X , Thomas-Jones, E orcid:0000-0001-7716-2786 , Carrol, ED orcid:0000-0001-8357-7726 , Whitbread, J, Owens, D, Pond, J, Cook, A, Oliver, Z, Douglas, C, Jordan, Z, Hawkins, R, Evans, J, Clarkstone, S, Maboshe, W, Goddard, M, Channon, S, Henley, J, Milosevic, S, Prout, H and Smallman, K (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). pp. 1-148. ISSN 1366-5278, 2046-4924 |