title: A randomized, observer-blind trial of amoxycillin/clavulanate versus cefaclor in the treatment of children with acute otitis media. Augmentin 415 Study Group.
abstract: In this randomized, multicenter, observer-blind study, the efficacy, safety and tolerability of amoxycillin/clavulanate and cefaclor were compared in children with a clinical diagnosis of acute otitis media. Patients aged between 1 and 12 years received either amoxycillin/clavulanate (250 mg/62 mg t.i.d., or 125 mg/31 mg t.i.d. if aged under 6 years) or cefaclor (250 mg t.i.d., or 125 mg t.i.d. if aged under 6 years) for 7 days. The amoxycillin/clavulanate regimen was based on a dose of 20/5 mg/kg/day (representing 20 mg amoxycillin plus 5 mg clavulanic acid) in three divided doses. Patients were followed-up at the end of therapy and on days 10-12 and 38-40. At the end of the study (days 38-40), clinical success rates were 91.4% for amoxycillin/clavulanate and 78.6% for cefaclor. The difference was statistically significant (p = 0.008). After the 7 days of treatment, 3 patients (2.9%) in the amoxycillin/clavulanate group had clinical failure, compared with 18 patients (16.1%) in the cefaclor group (p < 0.001). Both treatments were well tolerated and there were no statistically significant differences between the groups in adverse event profiles. The incidence of diarrhea was low (7.0% amoxycillin/clavulanate, 8.4% cefaclor) and was generally of mild or moderate intensity. The study demonstrated that amoxycillin/clavulanate was significantly more effective clinically than cefaclor in the treatment of acute otitis media in children.
authors.affiliation: St. John's Medical College Hospital, Bangalore, India.
authors.forename: S D
authors.initials: SD
authors.lastname: Subba Rao
authors.forename: M P
authors.initials: MP
authors.lastname: Macias
authors.forename: C A
authors.initials: CA
authors.lastname: Dillman
authors.forename: B D
authors.initials: BD
authors.lastname: Ramos
authors.forename: J S
authors.initials: JS
authors.lastname: Kierszenbaum
authors.forename: A E
authors.initials: AE
authors.lastname: Soliman
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000009:adverse effects / Q000627:therapeutic use*; D002433:Cefaclor / Q000627:therapeutic use*; D002511:Cephalosporins / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000188:drug therapy*; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D002511:Cephalosporins; D002433:Cefaclor; D019980:Amoxicillin-Potassium Clavulanate Combination