Treatment of acute uncomplicated urinary tract infections with 3 days of lomefloxacin compared with treatment with 3 days of norfloxacin.

The bacteriologic and clinical efficacies of 3 days of lomefloxacin therapy were compared with those of 3 days of norfloxacin therapy for the treatment of acute uncomplicated urinary tract infections in a prospective, randomized, double-blind study. One hundred sixty-four subjects were enrolled at five Canadian centers; 84 received lomefloxacin, and 80 received norfloxacin. Escherichia coli (84%) and Staphylococcus saprophyticus (11%) were the most common organisms isolated. Forty subjects (24%) had low quantitative counts in their pretherapy urine specimens. In the intent-to-treat analysis, 76 lomefloxacin subjects (91%) and 76 norfloxacin subjects (95%) were cured or improved at follow-up 5 to 9 days posttreatment and 73 (87%) and 71 (89%) subjects from the lomefloxacin and norfloxacin groups, respectively, were cured or improved at 4 to 6 weeks posttreatment. Bacteriologic eradication occurred in 61 of 63 lomefloxacin subjects (97%) with > or = 10(8) CFU/liter in their pretherapy specimens and 56 of 59 norfloxacin subjects (95%) at 5 to 9 days and 55 (87%) and 53 (90%) subjects from the lomefloxacin and norfloxacin groups, respectively, at 4 to 6 weeks. There were no statistically significant differences in outcome. Adverse effects which were potentially related to the study medications were reported by 26% of the subjects who received lomefloxacin and 25% of the subjects who received norfloxacin. There were no severe adverse events, and only one subject discontinued therapy. These data suggest that 3 days of therapy with either lomefloxacin or norfloxacin is effective in the treatment of acute uncomplicated urinary tract infections.