Fleroxacin versus norfloxacin in the treatment of urinary tract infections: a multicenter, double-blind, prospective, randomized, comparative study.

In a multicenter, double-blind, prospective, randomized, comparative study, fleroxacin, 400 mg once daily orally, was compared with norfloxacin, 400 mg twice daily orally. Each drug was given for 10 days to study efficacy and safety in the treatment of uncomplicated, recurrent, or complicated urinary tract infection (UTI). A total of 587 patients from 22 centers were enrolled and randomly assigned to fleroxacin (n = 291) or norfloxacin (n = 296). Of these, 163 patients in each group were included in the efficacy analysis, and 287 in the fleroxacin group and 292 in the norfloxacin group were included in the safety analysis. There was no difference between the two groups in terms of bacteriologic or clinical efficacy, with cure rates for each diagnostic subgroup of 93-100% in the fleroxacin group and 91-96% in the norfloxacin group. Superinfection, reinfection, or relapse, as well as development of resistance to the administered drugs, were infrequent and comparable in the two groups. Adverse events were documented in a significantly higher number of patients treated with fleroxacin and involved mainly the digestive system, the central nervous system, and the skin. However, > 90% of such adverse events were judged as mild or moderate in severity and did not lead to premature termination of treatment. Fleroxacin exhibited a clinical and bacteriologic efficacy comparable to that of norfloxacin in this group of patients, with cure rates similar to those of other 4-quinolones, suggesting a promising role for fleroxacin in the treatment of both uncomplicated and complicated UTIs. However, the higher incidence of adverse events with fleroxacin warrants further investigation with special focus on adverse reactions.