Amoxicillin for uncomplicated chest infections in children is unlikely to be clinically effective either overall or for key subgroups in whom antibiotics are commonly prescribed, say researchers from the ARTIC PC trial.
The randomised, double-blind placebo-controlled trial enrolled children from 56 general practices in England. Eligible children were those aged 6 months to 12 years presenting in primary care with acute uncomplicated lower respiratory tract infection of suspected infective origin, where pneumonia was not suspected clinically, who had had symptoms for less than 21 days.
Patients were randomised to receive amoxicillin 50mg/kg daily or placebo oral suspension, in three divided doses orally for 7 days. The primary outcome was the duration of symptoms rated moderately bad or worse, as measured using a validated diary, for up to 28 days or until symptom resolution.
From November 2016 to March 2020, 432 children were randomly assigned to the antibiotic group (n=221) or the placebo group (n=211). Complete data for symptom duration were available for 317 (73%) patients; missing data were imputed for the primary analysis.
Median durations of moderately bad or worse symptoms were comparable between the groups (5 days in the antibiotic group vs 6 days in the placebo group; hazard ratio 1.13 [95% CI 0.90–1.42]). No differences were seen for the primary outcome between the treatment groups in the five prespecified clinical subgroups (patients with chest signs, fever, physician rating of unwell, sputum or chest rattle, and short of breath).
The researchers concluded that, unless pneumonia is suspected, clinicians should provide safety-netting advice but not prescribe antibiotics for most children presenting with chest infections.