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Point-of-care decision rule for antibiotic prescriptions in young children with fever without source: an open cluster randomised trial

archdischild · 2026-03-17 · canonical JSON source

5 visible annotations · policy: published · automated confidence ≥ 75.00%

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Objective To evaluate whether a point-of-care decision rule could safely reduce antibiotic prescriptions in children presenting with fever without source in emergency departments.Design Open cluster randomised clinical trial (registered on ClinicalTrials.gov).Setting Twenty-five European paediatric emergency departments participated from November 2018 to October 2021.Patients Children aged 6 days to 36 months presenting with acute fever without source.Interventions During the first year, all centres (or clusters) followed their usual care protocols. In the second year, centres were randomised 1:1 to either continue usual care or to adopt the decision rule based on age, clinical symptoms, urine analysis and point-of-care procalcitonin measurements. In the third year, all centres applied the decision rule.Main outcomes and measures The primary outcome was antibiotic exposure within 15 days. Secondary outcomes included morbidity and mortality assessed at day 15.Results Among 4882 children (median age: 3 months, IQR 1–14), 2440 were in the usual care group and 2442 in the decision rule group. Serious bacterial infections occurred in 766 (15.7%) children, and invasive bacterial infections in 67 (1.4%). In the intention-to-treat analysis, 927 children (38.0%) received antibiotics within 15 days in the usual care group, compared with 641 (26.2%) in the decision rule group (OR 0.57; 95% CI 0.43 to 0.75; p<0.001). Morbidity and mortality rates were similar between groups (OR 0.83; 95% CI 0.57 to 1.22; p=0.34).Conclusions The decision rule safely reduced unnecessary antibiotic use in young children with fever without source in emergency departments.Trial registration number NCT03607162.