COMPARATIVE SAFETY AND EFFICACY OF CLARITHROMYCIN AND CEFADROXIL SUSPENSIONS IN THE TREATMENT OF MILD-TO-MODERATE SKIN AND SKIN-STRUCTURE INFECTIONS IN CHILDREN

A prospective, randomized, single (investigator) blind multicenter stu dy was performed to compare the safety and efficacy of clarithromycin and cefadroxil oral suspensions in the treatment of mild to moderate s kin and skin structure infections in children. Male and female patient s ages 6 months to 12 years were enrolled at 24 study centers in the U nited States. Patients had signs and symptoms consistent with mild to moderate skin or skin structure infections judged suitable for oral an timicrobial therapy. Clarithromycin oral suspension was given to 118 c hildren in a dose of 7.5 mg/kg (maximum of 500 mg) twice daily; cefadr oxil oral suspension was given to 113 children in a dose of 15 mg/kg ( maximum of 1000 mg) twice daily. Among clinically evaluable patients c linical success rates (cure plus improvement) were 96% (71 of 74) for clarithromycin and 98% (83 of 85) for cefadroxil (P = 0.664). Bacterio logic cure rates in evaluable clarithromycin and cefadroxil patients w ere 96% (72 of 75) and 99% (89 of 90), respectively (P = 0.331). Patho gen eradication rates based on 204 evaluable pathogens were 97% in the clarithromycin group and 99% in the cefadroxil group (P = 0.326). Adv erse events were mild or moderate and were reported in 25% of clarithr omycin and 35% of cefadroxil patients (P = 0.085). In both groups adve rse events involved primarily the digestive tract. No significant labo ratory changes were noted. Clarithromycin oral suspension appears to b e a safe and effective alternative to cefadroxil for the treatment of pediatric skin and skin structure infections.