Patients older than 18 years with acute lower-respiratory-tract infections (cough of ¡Ü28 days' duration) in whom pneumonia was not suspected were randomly assigned (1:1) to either amoxicillin (1 g three times daily for 7 days) or placebo by computer-generated random numbers. Our primary outcome was duration of symptoms rated ¡°moderately bad¡± or worse. Secondary outcomes were symptom severity in days 2-4 and new or worsening symptoms. Investigators and patients were masked to treatment allocation. This trial is registered with EudraCT (2007-001586-15), UKCRN Portfolio (ID 4175), ISRCTN (52261229), and FWO (G.0274.08N).
1038 patients were assigned to the amoxicillin group and 1023 to the placebo group. Neither duration of symptoms rated ¡°moderately bad¡± or worse (hazard ratio 1¡¤06, 95 % CI 0¡¤96-1¡¤18; p=0¡¤229) nor mean symptom severity (1¡¤69 with placebo vs 1¡¤62 with amoxicillin; difference ?0¡¤07 [95 % CI ?0¡¤15 to 0¡¤007]; p=0¡¤074) differed significantly between groups. New or worsening symptoms were significantly less common in the amoxicillin group than in the placebo group (162 [15¡¤9 % ] of 1021 patients vs 194 [19¡¤3 % ] of 1006; p=0¡¤043; number needed to treat 30). Cases of nausea, rash, or diarrhoea were significantly more common in the amoxicillin group than in the placebo group (number needed to harm 21, 95 % CI 11-174; p=0¡¤025), and one case of anaphylaxis was noted with amoxicillin. Two patients in the placebo group and one in the amoxicillin group needed to be admitted to hospital; no study-related deaths were noted. We noted no evidence of selective benefit in patients aged 60 years or older (n=595).
When pneumonia is not suspected clinically, amoxicillin provides little benefit for acute lower-respiratory-tract infection in primary care both overall and in patients aged 60 years or more, and causes slight harms.
European Commission Framework Programme 6, UK National Institute for Health Research, Barcelona Ciberde Enfermedades Respiratorias, and Research Foundation Flanders.