A SINGLE-BLIND, RANDOMIZED, COMPARATIVE-STUDY OF CLARITHROMYCIN AND AMOXICILLIN SUSPENSIONS IN THE TREATMENT OF CHILDREN WITH LOWER RESPIRATORY-TRACT INFECTIONS

One hundred and forty-five children with signs and symptoms of lower r espiratory tract infections were entered into this multicentre, Genera l Practice, investigator-blind study, designed to demonstrate equivale nt efficacy between clarithromycin and amoxycillin suspensions. Sevent y one children were randomised to treatment with clarithromycin suspen sion 7.5 mg/kg bodyweight twice daily and 74 to treatment with amoxyci llin suspension 125 mg (bodyweight < 25 kg) or 250 mg (bodyweight grea ter-than-or-equal-to 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 chi ldren 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 cl inical cure rate (60% for clarithromycin and 63% for amoxycillin), cli nical success rate (cure plus improvement, 96% for clarithromycin and 95% for amoxycillin) or rate of resolution of clinical signs and sympt oms in clinically evaluable patients. The intention to treat analysis for all patients entered similarly showed no significant differences i n efficacy. The two treatment groups did not differ significantly with respect to incidence or severity of adverse events which were general ly mild and associated with the gastrointestinal system. Therapy was w ithdrawn because of adverse events in three children on clarithromycin and one on amoxycillin. Bacteriological cure rates could not be deter mined because of an insufficient number of evaluable pre-treatment spu tum samples. The results of this study indicate that the efficacy and tolerability of twice daily clarithromycin suspension is equivalent to that of three times daily amoxycillin suspension in the treatment of children with lower respiratory tract infections.