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

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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.

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