Sultamicillin (sulbactam/ampicillin) versus amoxycillin in the treatment of acute otitis media in children.

A comparative study of sultamicillin (an orally active dimer of sulbactam and ampicillin) and amoxycillin for the treatment of acute otitis media was carried out in 86 children with acute otitis media. After 10 days' treatment, of those with traditional middle ear pathogens, 35/36 (97%) 50 mg/kg.day or 500 mg/day sultamicillin-treated children were cured with eight relapses after a further 18 days without treatment compared with 12/13 (92%) 40 mg/kg.day or 250 mg/day amoxycillin-treated children and three subsequent relapses. All six beta-lactamase-producing pathogens were in the sultamicillin treatment group: four were Haemophilus influenzae/H. parainfluenzae that were resistant to amoxycillin, and all were cured although two then relapsed. No significant clinical or laboratory side-effects were noted in either amoxycillin- or sultamicillin-treated patients. It is concluded that sultamicillin was comparable to amoxycillin in the treatment of acute otitis media.