A procalcitonin-based rule cut antibiotic use by a third in febrile infants with no source

Design

Open cluster-randomised trial, 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

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

This open cluster-randomised trial ran in 25 European paediatric emergency departments from 2018 to 2021. It enrolled 4,882 children aged 6 days to 36 months (median 3 months) with fever without source. After a year of usual care, centres were randomised to continue usual care or adopt a decision rule using age, clinical signs, urinalysis and point-of-care procalcitonin.

Serious bacterial infections occurred in 15.7% and invasive infections in 1.4%. Antibiotic exposure within 15 days was 26.2% with the rule against 38.0% with usual care (OR 0.57, 95% CI 0.43 to 0.75). Morbidity and mortality at day 15 were similar (OR 0.83, 0.57 to 1.22).

In this trial the rule reduced antibiotic use without a detected increase in morbidity or mortality. Point-of-care procalcitonin is not widely available in Indian emergency departments, but laboratory procalcitonin and urinalysis often are, and the principle of structured risk assessment applies.

• In children under 3 with fever without source, use a structured risk rule rather than routine antibiotics.
• Combine age, clinical appearance, urinalysis and procalcitonin to identify low-risk children.
• Beyond the neonatal period, a low procalcitonin with a normal urinalysis in a well-appearing child supports withholding antibiotics.
• Arrange clear safety-netting and review within 24 to 48 hours for children sent home without antibiotics.
• Febrile infants in the first month of life follow the local febrile-infant pathway, usually full work-up and parenteral antibiotics; this rule does not replace it.

Why it matters

It gives emergency clinicians a tested way to withhold antibiotics from the many febrile infants who do not need them.

Don't overread it

The trial was open-label and the safety outcome was secondary; very rare serious infections may still be missed.

The statistics, in plain English

An odds ratio of 0.57 corresponds to antibiotic use falling from 38 to 26 in every 100 children. The safety comparison (OR 0.83, 0.57 to 1.22) crosses 1.0, meaning no difference was detected, but the trial was not powered to exclude small differences in rare harms.

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