ABSTRACT
In a multicenter randomized double-blind, trial, 90 patients received either fleroxacin 400mg po once/day or ciprofloxacin 500mg po twice/day for treatment of complicated urinary tract infections (UTI). Treatment was administered orally and presumptively. Bacteriological efficacy was assessed 7 days post-treatment. In total, 78 patients were available for efficacy testing: 40 in the fleroxacin group and 38 in the ciprofloxacin group. The bacteriological cure rate was 92.5 percent and 94.7 and in the fleroxacin and ciprofloxacin groups, respectively. The most commonly isolated pathogen (E. coli) was erradicated in 94.1 percent and 95.8 percent of the cases in fleroxacin and ciprofloxacin groups, respectively. Eight patients in the fleroxacin group had some adverse events, two of them severe (insomnia and photodermatitis). In the ciprofloxacin group, 11 patients had adverse events of mild to moderate intensity, mainly affecting the digestive system. In conclusion, fleroxacin 400mg po once/day and ciprofloraxin 500mg po twice/day were both effective in the treatment of complicated urinary tract infections.