Comparison of the safety and efficacy of lomefloxacin and trimethoprim/sulfamethoxazole in the treatment of uncomplicated urinary tract infections: results from a multicenter study.

Lomefloxacin, a new difluorinated quinolone, and trimethoprim/sulfamethoxazole (TMP/SMX) were compared in the treatment of adults with uncomplicated urinary tract infections. The study was conducted as a multicenter, controlled, prospectively randomized, single-blind study in five countries (Argentina, Belgium, Brazil, Mexico, and Venezuela). A total of 254 patients were enrolled: 129 in the lomefloxacin group and 125 in the TMP/SMX group. Patients received either 400 mg lomefloxacin orally once daily or 160 mg/800 mg TMP/SMX orally twice daily for 7-10 days. Escherichia coli and Proteus mirabilis were the pathogens most frequently isolated. At 5-9 days post-therapy, satisfactory bacteriologic results were noted in 98.4% of patients treated with lomefloxacin and in 95.8% of patients in the TMP/SMX group (p = 0.2153). Clinical success 5-9 days post-therapy was noted in 99.2% of patients in the lomefloxacin group and in 98.3% of patients in the TMP/SMX group (p = 0.5138). Adverse events probably related to treatment occurred in 6% of those treated with lomefloxacin and in 7% of patients treated with TMP/SMX. Once-daily oral lomefloxacin is a well-tolerated and effective treatment of uncomplicated urinary tract infections caused by susceptible pathogens.