Trimethoprim-sulfamethoxazole compared with ampicillin in the treatment of acute otitis media.

We treated 132 children with acute otitis media in a randomized trial comparing trimethoprim-sulfamethoxazole and ampicillin. The antibacterial efficacy of the drugs was assessed primarly from the results of cultures of middle ear aspirates obtained during or after the course of therapy; persistent, recurrent, and new infections of the middle ear were documented in both groups of patients but did not differ significantly. Both drug regimens were well accepted by the patients and were not associated with serious side effects or toxicity. TMP-SMZ is an effective alternate to AMP or to other accepted regimens for initial treatment of acute otitis media.