A point-of-care rule cut antibiotic use in febrile young children without more illness

Design

Open cluster randomised trial across 25 paediatric emergency departments

Population

4,882 children aged 6 days to 36 months with fever without source

Primary outcome

Antibiotic exposure within 15 days

Effect

38.0% vs 26.2%; OR 0.57 (95% CI 0.43 to 0.75); morbidity and mortality OR 0.83 (0.57 to 1.22)

This open cluster randomised trial ran in 25 European paediatric emergency departments from 2018 to 2021. It included 4,882 children aged 6 days to 36 months with acute fever and no source after assessment. In year one every centre used usual care; in year two centres were randomised to continue usual care or to a decision rule based on age, clinical symptoms, urinalysis and point-of-care procalcitonin; in year three all centres used the rule.

Antibiotic exposure within 15 days was 38.0% (927 of 2,440) with usual care and 26.2% (641 of 2,442) with the rule (OR 0.57, 95% CI 0.43 to 0.75). Serious bacterial infection occurred in 15.7% of all children and invasive infection in 1.4%. Morbidity and mortality were similar between arms (OR 0.83, 95% CI 0.57 to 1.22).

The rule relies on point-of-care procalcitonin, which many Indian emergency departments lack. Even then, the trial supports the principle that a structured, test-supported approach can limit unnecessary antibiotics without more harm, and the confidence interval for morbidity was wide enough that smaller differences cannot be excluded.

• Use an explicit local pathway for fever without source in infants, with age-based thresholds
• Include urinalysis in the assessment, since a urinary source is common in this age group
• Procalcitonin, where available, is part of the tested rule; do not use it alone
• Arrange safety-netting and follow-up for children sent home without antibiotics
• Infants in the first weeks of life remain a high-risk group needing local neonatal protocols

Why it matters

It shows antibiotic reduction can be built into a pathway rather than left to individual caution.

Don't overread it

The rule needs point-of-care procalcitonin and European emergency department resources, and results may not transfer to settings without them.

The statistics, in plain English

An odds ratio of 0.57 means the odds of receiving antibiotics were about 43% lower with the rule. The harm comparison (OR 0.83, 95% CI 0.57 to 1.22) is not significant, but its interval is wide, so a small increase in harm cannot be fully excluded. An open design means clinicians knew which arm they were in.

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