Comparison of fleroxacin and amoxicillin in the treatment of uncomplicated urinary tract infections in women.

Fleroxacin, 400 mg, was compared with amoxicillin, 3,000 mg, each administered orally in a single dose, for the treatment of women with acute uncomplicated symptomatic urinary tract infections. A total of 142 patients were randomized to receive fleroxacin, and 147 patients to receive amoxicillin. Of these, 33 in the fleroxacin group and 39 in the amoxicillin group were considered bacteriologically evaluable. Cure at 5-9 days after treatment was achieved in 32 (97%) of the fleroxacin-treated patients and in 22 (56%) of the amoxicillin-treated patients (p < 0.001). For the most frequently isolated pathogen (Escherichia coli), all 24 isolates were eradicated in the fleroxacin group, as were 11 of 25 in the amoxicillin group. At 6 weeks after therapy, bacteriologic cure was maintained in 20 (95%) of the 21 evaluable patients who received fleroxacin and in 8 (89%) of 9 evaluable patients who received amoxicillin. There were no reinfections in either group. A total of 280 patients were assessed for safety. Clinical adverse events were reported in 32 (23%) of 137 patients in the fleroxacin group and in 19 (13%) of the 143 patients in the amoxicillin group. In both groups, the most common adverse effects were gastrointestinal, while adverse events involving the central nervous system were more frequent in patients who received fleroxacin. On the basis of this study, it appears that fleroxacin is demonstrably more effective than amoxicillin as single-dose therapy for uncomplicated urinary tract infection.