The efficacy and tolerability of flurithromycin and clarithromycin in the treatment of bacterial upper respiratory tract infections were compared in a multicenter, parallel-group, double-masked, double-dummy study of 320 adult patients who were randomized to two treatment groups. Flurithromycin was administered as one 375-mg tablet twice daily and clarithromycin as one 250-mg tablet twice daily for up to 14 days. In the flurithromycin group, 3 patients were lost to observation, 1 withdrew because of poor compliance and I because of diarrhea, and 2 were considered clinical failures at treatment completion. In the clarithromycin group, 2 patients withdrew for treatment inefficacy and 12 were considered clinical failures at treatment completion. All other patients were judged to be cured or improved. Thus the intent-to-treat success rates were 153 (95.6%) of 160 patients in the flurithromycin group and 146 (91.3%) of 160 patients in the clarithromycin group; the difference was not statistically significant. The eradication rate of the baseline pathogens, mostly gram-positive cocci, was 123 (90.4%) of 136 patients in the flurithromycin group and 126 (91.3%) of 138 patients in the clarithromycin group. Response rates did not vary appreciably by infection site or baseline pathogen. Adverse events, mostly mild-to-moderate gastrointestinal disturbances, were observed in 8 patients (5.0%) in the flurithromycin group and in 11 patients (6.9%) in the clarithromycin-group. These results suggest that flurithromycin 375 mg twice daily is as effective and well tolerated as clarithromycin 250 mg twice daily in the treatment of upper respiratory tract infections.
- Upper respiratory tract infection
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