Amoxicillin not clinically effective in uncomplicated chest infections in kids: Lancet

UK: Amoxicillin is not likely to be clinically effective (either overall or for key subgroups in whom antibiotics are commonly prescribed) for uncomplicated chest infections in children, reports a recent study in The Lancet journal. Based on the findings, the researchers suggest that for most children presenting with chest infections, clinicians should provide safety-netting advice but not prescribe antibiotics unless pneumonia is suspected.

WHO and the UK Department of Health have recognized that antibiotic resistance is a serious global health problem, with rising resistance rates for a range of antibiotics. Acute respiratory tract infections (RTI) are among the commonest conditions in children managed in primary care.

Prof Paul Little, University of Southampton, Southampton, UK, and colleagues aimed to evaluate whether amoxicillin reduces the duration of moderately bad symptoms in children presenting with uncomplicated (non-pneumonic) LRTI in primary care, overall and in key clinical subgroups.

The study was designed as a double-blinded, randomised, placebo-controlled trial conducted at 56 general practices in England. Eligible children who were aged 6 months to 12 years presenting in primary care with acute uncomplicated LRTI judged to be infective in origin, where pneumonia was not suspected were considered eligible clinically, with symptoms for less than 21 days. Patients were randomly assigned in a 1:1 ratio to receive amoxicillin 50 mg/kg per day or placebo oral suspension, in three divided doses orally for 7 days. Patients and investigators were masked to treatment assignment. The primary outcome was the duration of symptoms rated moderately bad or worse (measured using a validated diary) for up to 28 days or until symptoms resolved. The primary outcome and safety were assessed in the intention-to-treat population.

A total of 432 children between Nov 9, 2016, and March 17, 2020, were included except(not including six who withdrew permission for use of their data after randomisation) were randomly assigned to the antibiotics group were n=221 or the placebo group was n=211. Complete data for symptom duration were available for 317 (73%) patients; missing data were imputed for the primary analysis.

The results of the study were found to be

• Median durations of moderately bad or worse symptoms were similar between the groups (5 days [IQR 4–11] in the antibiotics group vs 6 days [4–15] in the placebo group; hazard ratio [HR] 1•13).

• No differences were found 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). Estimates from complete-case analysis and a per-protocol analysis were similar to the imputed data analysis.

Prof Little and team concluded that "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. Unless pneumonia is suspected, clinicians should provide safety-netting advice but not prescribe antibiotics for most children presenting with chest infections."

For further information: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01431-8/fulltext