Clinical Question

Is amoxicillin beneficial for children six months to 12 years of age with a lower respiratory tract infection that is not pneumonia?

Bottom Line

A high dosage of amoxicillin (50 mg per kg per day, in three divided doses) did not significantly improve outcomes for children with a lower respiratory tract infection that is not pneumonia. (Level of Evidence = 1b)

Synopsis

The investigators identified 432 children six months to 12 years of age who presented to their primary care physician in the United Kingdom with lower respiratory tract infection symptoms for less than 21 days, but with no clinical signs indicating possible pneumonia. All of the patients had acute cough with signs and symptoms that localized the infection to the lower respiratory tract, such as shortness of breath, sputum production, or pain. The children were randomized (concealed allocation) to receive amoxicillin, 50 mg per kg per day in three divided doses, or matching placebo. Nasal swabs were taken to look for common respiratory pathogens, and parents kept symptom diaries for 28 days or until symptoms had resolved. The median age of participants was 3.2 years, 54% were boys, 13% had a comorbidity, and only 28% had received the influenza vaccine in the past year. The authors had complete follow-up data for 73% of the patients, and they imputed missing data where possible. The primary outcome was the duration of moderately bad or worse respiratory symptoms and did not differ between groups (five days for antibiotics; six days for placebo; hazard ratio = 1.13; 95% CI, 0.90 to 1.42). There was also no difference in secondary outcomes, such as the likelihood of hospitalization, returning with new or worsening symptoms, symptom severity, or the duration until the symptoms were reported to be mild. There were no differences between groups in adverse events. A high dose of amoxicillin is recommended for pathogens with intermediate levels of resistance. Only two patients in the placebo group and five in the antibiotics group had atypical bacterial pathogens, such as Chlamydia pneumoniae, Mycoplasma pneumoniae, Bordetella pertussis, Streptococcus pyogenes, or Fusobacterium necrophorum, that would not be expected to respond to amoxicillin.

Study design: Randomized controlled trial (double-blinded)

Funding source: Government

Allocation: Concealed

Setting: Outpatient (primary care)

Reference: Little P, Francis NA, Stuart B, et al. Antibiotics for lower respiratory tract infection in children presenting in primary care in England (ARTIC PC): a double-blind, randomised, placebo-controlled trial. Lancet. 2021;398(10309):1417–1426.

Editor's Note: Dr. Ebell is deputy editor for evidence-based medicine for AFP and cofounder and editor-in-chief of Essential Evidence Plus, published by Wiley-Blackwell.