Amoxicillin-clavulanate potassium compared with cefaclor for acute otitis media in infants and children.
One hundred thirty-three infants and children with documented acute otitis media (OM) were randomized to receive the oral suspension of either amoxicillin-clavulanate potassium or cefaclor. Beta-lactamase-producing bacteria were found in 10.9 and 14.5% of subjects treated with amoxicillin-clavulanate potassium and cefaclor, respectively. Subjects were reexamined at 5, 10, 30, 60 and 90 days after the initiation of therapy and whenever signs/symptoms of acute otitis media recurred. All but two children had resolution of otalgia/otorrhea during the initial treatment period. The drug groups were not significantly different in the percentage of evaluable subjects with otitis media with effusion at each scheduled follow-up visit. Recurrence of acute OM/otorrhea [corrected] developed in a similar percentage of subjects in both treatment categories. Both subjects with and those without middle ear effusion at 10 days had approximately a 50% recurrence rate of subsequent middle ear disease. Adverse side effects/complaints, which occurred in significantly more children treated with amoxicillin-clavulanate potassium, were generally mild and primarily gastrointestinal.
D000208:Acute Disease; D000658:Amoxicillin / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination; D002433:Cefaclor / Q000627:therapeutic use*; D002506:Cephalexin / Q000031:analogs & derivatives*; D002648:Child; D002675:Child, Preschool; D002969:Clavulanic Acids / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004338:Drug Combinations / Q000627:therapeutic use; D004433:Earache; D005260:Female; D005334:Fever; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D010034:Otitis Media with Effusion / Q000188:drug therapy; D011897:Random Allocation; D012008:Recurrence
D002969:Clavulanic Acids; D004338:Drug Combinations; D002433:Cefaclor; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin; D002506:Cephalexin