A randomized, observer-blind trial of amoxycillin/clavulanate versus cefaclor in the treatment of children with acute otitis media. Augmentin 415 Study Group

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...

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Bibliographic Details
Published in:Journal of chemotherapy (Florence) 1998-12, Vol.10 (6), p.460
Main Authors: Subba Rao, S D, Macias, M P, Dillman, C A, Ramos, B D, Kierszenbaum, J S, Soliman, A E
Format: Article
Language:English
Subjects:
Acute Disease
Administration, Oral
Amoxicillin-Potassium Clavulanate Combination - adverse effects
Amoxicillin-Potassium Clavulanate Combination - therapeutic use
Cefaclor - therapeutic use
Cephalosporins - therapeutic use
Child
Child, Preschool
Drug Therapy, Combination - adverse effects
Drug Therapy, Combination - therapeutic use
Female
Humans
Infant
Male
Otitis Media - drug therapy
Single-Blind Method
Treatment Outcome
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Summary: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.
ISSN:1120-009X