An open comparative study of the efficacy and safety of sultamicillin versus cefaclor in the treatment of acute otitis media in children.
In an open study, children (age range 6 months-12 years) with otitis media due to a bacterial infection were treated orally with 50 mg/kg sultamicillin (n = 30) in two equal doses each day for a mean of 10 days, or 40 mg/kg cefaclor (n = 30) in three equal doses each day for a mean of 11 days. Earache was rapidly improved by either treatment; none of the 27 evaluable sultamicillin-treated or the 29 evaluable cefaclor-treated patients had earache after 8-10 days. Other signs and symptoms (reddened eardrums, perforated eardrums, middle ear fluid, hearing loss) gradually improved during treatment. All the pathogens isolated from patients in the sultamicillin treatment group were eradicated, as were all but one of the pathogens isolated from patients in the cefaclor treatment group. In the sultamicillin treatment group 65.4% of patients were cured and 34.6% were improved, and in the cefaclor group 65.5% were cured and 31.0% improved, but there was one treatment failure. Study drug-related adverse events were experienced by 33.3% of sultamicillin- and 40.0% of cefaclor-treated patients, all but one (urticaria in a cefaclor-treated patient) were gastro-intestinal. The dose administered was reduced by approximately 50% in patients experiencing adverse effects. This did not lead to any reduction in efficacy and no patient was withdrawn due to adverse events.
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D000208:Acute Disease; D000284:Administration, Oral; D000667:Ampicillin / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D002433:Cefaclor / Q000009:adverse effects / 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*; D013407:Sulbactam / Q000009:adverse effects / Q000627:therapeutic use*
C035444:sultamicillin; D002433:Cefaclor; D000667:Ampicillin; D013407:Sulbactam