A single-blind, randomised, comparative study of clarithromycin and amoxycillin suspensions in the treatment of children with lower respiratory tract infections

Abstract

One hundred and forty-five children with signs and symptoms of lower respiratory tract infections were entered into this multicentre, General Practice, investigator-blind study, designed to demonstrate equivalent efficacy between clarithromycin and amoxycillin suspensions. Seventy one children were randomised to treatment with clarithromycin suspension 7.5 mg/kg bodyweight twice daily and 74 to treatment with amoxycillin suspension 125 mg (bodyweight < 25 kg) or 250 mg (bodyweight > or = 25 kg) three times a day according to bodyweight. Duration of therapy was 5-10 days as determined by the investigator. Clinical evaluations were performed pretreatment, during treatment and post-treatment within 72 hours of cessation of therapy. Fifty two children in the clarithromycin group and 57 in the amoxycillin group were clinically evaluable. Both study medications were effective and there were no significant differences between the groups with respect to clinical cure rate (60% for clarithromycin and 63% for amoxycillin), clinical success rate (cure plus improvement, 96% for clarithromycin and 95% for amoxycillin) or rate of resolution of clinical signs and symptoms in clinically evaluable patients. The intention to treat analysis for all patients entered similarly showed no significant differences in efficacy. The two treatment groups did not differ significantly with respect to incidence or severity of adverse events which were generally mild and associated with the gastrointestinal system. Therapy was withdrawn because of adverse events in three children on clarithromycin and one on amoxycillin. Bacteriological cure rates could not be determined because of an insufficient number of evaluable pre-treatment sputum samples.(ABSTRACT TRUNCATED AT 250 WORDS)