Comparison of intravenous fleroxacin with ceftazidime for treatment of complicated urinary tract infections.

Intravenous fleroxacin, 400 mg once daily, was compared with intravenous ceftazidime, 0.5-2 g three times a day or 1-2 g twice a day, administered for 4-21 days for treatment of complicated urinary tract infections (UTIs) due to susceptible organisms. Fleroxacin also was tested in an uncontrolled trial. The trial was a multicenter, randomized, open-label study of adults with pyelonephritis or signs and symptoms of UTI and complicating factors. In the controlled trial, 474 patients were randomly assigned in a 2:1 ratio to receive fleroxacin (n = 320) or ceftazidime (n = 154). The microbiologic criterion for diagnosis of UTI was the isolation of > or = 10(5) colony-forming units (CFU) of pathogenic bacteria/mL of urine. The efficacy analyses included 165 fleroxacin-treated and 82 ceftazidime-treated patients in the controlled trial and 97 patients in the uncontrolled trial. In the controlled trial, 317 fleroxacin-treated and 150 ceftazidime-treated patients were included in the safety analysis. In the controlled trial, the respective rates of bacteriologic cure (< or = 10(4) CFU/mL of urine 48-96 hours after first dose and 2-5 days posttherapy) were 94% (confidence interval [CI], 89-97%) and 95% (CI, 88-99%) in the fleroxacin and ceftazidime groups, and those of clinical cure were 86% (CI, 80-91%) and 89% (CI, 80-95%). Rates of clinical and bacteriologic cure in the uncontrolled study were 95%. In the controlled trial, 9% of the patients in each treatment group experienced one or more adverse events possibly or probably related to the study drug. The percentage of patients terminating therapy prematurely was higher in the fleroxacin than in the ceftazidime group. Once-daily dosing with 400 mg of intravenous fleroxacin was equivalent to a standard multidose regimen with respect to rates of bacteriologic and clinical cure in the treatment of complicated UTI.