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.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.

[Acute and secretory otitis media] / Otite média aguda e secretora.

OBJECTIVE: Otitis media is the most frequently diagnosed infection in the pediatric office. Ninety per cent of the children present at least one episode of otitis media before the fifth birthday. We reviewed the literature in order to update information regarding the current definitions of acute otitis media, recurrent otitis media and otitis media with effusion, analyzing the predisposing factors, microbiology, clinical manifestations, diagnostic criteria and methods of treatment for these entities, and the relationship between otitis media and language development and learning disabilities.DATA SOURCE: Bibliographic review of an eighteen- year period (1980-1998) using Index Medicus and Medline.RESULTS AND CONCLUSIONS: More than 25 million diagnoses per year of middle ear infections are made in the United States, being responsible for rising costs of treatment. The role of many predisposing factors is presently well recognized and we should be capable of defining interventions related to some of them as is the case of early institution of day-care, short duration of breast feeding and difficulties in the identification and treatment of gastroesophageal reflux. Changes in the microbiology of the middle ear infections and the emergence of multiresistant bacteria leads to modifications in antibiotic therapy and the duration of its use. Antibacterial agents should be prescribed only in the presence of a well-defined diagnosis and chemoprophylaxis should be avoided. Recurrent otitis media and otitis media with effusion in infants may be associated to speech disorders and learning disabilities. The development of a conjugated vaccine against S. pneumoniae and the experiments with a vaccine against non-typeable H. influenzae represent a big step in the prevention of infections of the middle ear for the near future.