A point-of-care rule cut antibiotic exposure in febrile infants without more harm

Design

Open, stepped cluster randomised clinical trial in 25 European 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

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

In this open cluster randomised trial, 25 European paediatric emergency departments took part from 2018 to 2021. In year one all used usual care. In year two centres were randomised to continue usual care or to use a decision rule based on age, clinical symptoms, urine analysis and point-of-care procalcitonin. In year three all applied the rule. The 4,882 children were aged 6 days to 36 months with fever without source (median age 3 months).

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; P below 0.001). Morbidity and mortality at day 15 were similar (OR 0.83, 95% CI 0.57 to 1.22). Serious bacterial infection occurred in 15.7% and invasive bacterial infection in 1.4%.

The rule depends on point-of-care procalcitonin, which is not widely available in Indian emergency settings, and the trial was in European emergency departments. Outcomes were assessed at 15 days, and the trial was too small to exclude a rare missed invasive infection. It supports structured, protocol-led decisions over habit.

• If your department has point-of-care procalcitonin, consider a structured rule combining age, symptoms and urine analysis.
• Where it is not available, use your local febrile-infant protocol rather than treating on impression.
• Keep a low threshold for cultures and treatment in the youngest infants.
• Document the reason for or against antibiotics and arrange safety-net review.

Why it matters

It shows that antibiotic use in febrile infants can fall substantially under a rule, not only through clinician restraint.

Don't overread it

The rule depends on procalcitonin testing and was assessed in European emergency departments; the trial cannot exclude a small rise in rare missed infections.

The statistics, in plain English

An odds ratio of 0.57 means about 43% lower odds of receiving antibiotics. In absolute terms that was about 12 fewer children per 100 treated. The similar morbidity and mortality (OR 0.83, interval 0.57 to 1.22) shows no signal of harm, though the trial could not exclude small increases in rare events.

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