A SAFETY AND EFFICACY COMPARATIVE-STUDY OF CLARITHROMYCIN AND AMOXILLIN CLAVULANATE SUSPENSIONS IN THE SHORT-COURSE TREATMENT OF CHILDREN WITH ACUTE OTITIS-MEDIA

We evaluated the safety and efficacy of short course treatment We eval uated the safety and efficacy of short course treatment with a new ora l suspension of clarithromycin in this open, comparative, multicentre trial against amoxicillin/clavulanate in 224 children, 5 months to 7 y ears of age, with acute otitis media. Children were randomized to rece ive a 5-day course of clarithromycin oral suspension (7.5 mg/kg/dose; maximum 500 mg) twice daily or amoxicillin/clavulanate oral suspension (7-10 mg/kg/dose) three times daily. Specific clinical response crite ria were defined based on pretreatment signs and symptoms. Data were s uitable for analysis in 218 (97%) of 224 patients enrolled (clarithrom ycin, 110; amoxicillin/clavulanate, 108). We found no demographic diff erences between the two groups. The infection was of moderate severity in 67% of patients. The two suspensions showed similar efficacy in th e treatment of acute otitis media. Clinical success rate (cure and cur e with effusion or improvement) was achieved at the end of treatment i n 96% and 97% of clarithromycin- and amoxicillin/clavulanate-treated p atients, respectively. Both drugs were well-tolerated. Overall adverse event rates for clarithromycin (7%) and amoxicillin/clavulanate (16.5 %) oral suspensions revealed fewer events with clarithromycin. More ga strointestinal adverse events were reported in the amoxicillin/clavula nate group as compared with the clarithromycin group (11% and 4%, resp ectively; p=0.04). A 5-day regimen of clarithromycin suspension (7.5 m g/kg twice daily) appears to be as safe and effective as amoxicillin/c lavulanate, and better tolerated in the treatment of acute otitis medi a in children.