Efficacy and tolerability of an amoxycillin/clavulanic acid combination in the treatment of common bacterial infections. A general practitioner trial

Abstract

The efficacy and tolerability of a combination of amoxycillin 250 mg and clavulanic acid 125 mg (A-CA) (Augmentin; Beecham) was evaluated under general practice conditions. One hundred and sixty-four patients were treated with either A-CA tablets or amoxycillin 250 mg capsules, taken 3 times daily for 7 days at the start of a meal. Ten patients with treatment failure on amoxycillin were re-treated with A-CA. In the initial stage of the trial 102 patients were randomly allocated to either amoxycillin or A-CA treatment; of these 89 could be assessed clinically and 63 could be assessed bacteriologically, of whom 32 had received amoxycillin and 31 A-CA treatment. Subsequently a further 62 patients were treated with A-CA; 50 were assessed clinically and 40 bacteriologically. Bacteriological assessment was possible in 109 patients, 71 on A-CA, 32 on amoxycillin, and 6 who received A-CA after having failed on amoxycillin treatment. In this study A-CA was bacteriologically significantly superior to amoxycillin in treating urinary tract infections (P less than 0,024), skin and soft tissue infections (P less than 0.05) and all infections caused by amoxycillin-resistant organisms (P less than 0.013). No difference was shown in infections caused by amoxycillin-sensitive organisms. Side-effects most commonly associated with A-CA treatment were gastro-intestinal (6,7%) and consisted of nausea and diarrhoea. This trial has a special significance for general practitioners in that it shows a high incidence of penicillin-resistant organisms (51%). This observation, as yet limited to one area in South Africa, has wide implications for general practice management of infections.