Comparison of cefaclor and trimethoprim-sulfamethoxazole in the treatment of acute otitis media.

The efficacy and safety of cefaclor and trimethoprim-sulfamethoxazole (TMP-SMX) were compared in 100 children with acute otitis media assigned to the two treatment groups in a double-blind, randomized fashion. Treatment was for 10 days. Each patient had a diagnostic tympanocentesis before starting therapy. Pathogens were isolated from the middle ear aspirate in 49% of the cases, and organisms considered nonpathogenic were isolated as pure cultures from an additional 19%. Of the 100 patients 4 of 50 in the cefaclor group and 2 of 50 in the TMP-SMX group were considered treatment failures. In three of the four failures with cefaclor, compliance with the first course of therapy could not be ascertained. All six patients showed a good therapeutic response to an additional 10-day course of cefaclor. We conclude that cefaclor and TMP-SMX have essentially equivalent efficacy in the treatment of acute otitis media.