A comparative study of pazufloxacin mesilate (T-3762) and ceftazidime (CAZ) in the treatment of complicated urinary tract infections

To assess the efficacy, safety, and usefulness of the new quinolone drug pazufloxacin mesilate (T-3762) for injection in the treatment of complicated urinary tract infections, a comparative study was conducted using ceftazidime (CAZ), an antibacterial cephem, as the control drug. These test drugs were intravenously administered by drip infusion for 5 days at 500 mg (b. i. d.), based on pazufloxacin (PZFX, developmental code: T-3761, active moiety of T-3762) for T-3762, and at 1,000 mg (b. i. d.) for CAZ. The following results were obtained. The test drugs were administered to a total of 300 patients: 146 in the T-3762 group and 154 in the CAZ group. Of these patients, 107 in the T-3762 group and 119 in the CAZ group were evaluated for efficacy, 135 in the T-3762 group and 144 in the CAZ group were evaluated for overall safety, while 108 in the T-3762 group and 116 in the CAZ group were evaluated for usefulness. The overall clinical efficacy rates according to the UTI Criteria were 92.5% (99/107) for the T-3762 group and 87.4% (104/119) for the CAZ group, showing no significant difference between the two groups. Regarding bacteriological response, the eradication rates on the first day were 86.2% (150/174) for the T-3762 group and 829% (165/199) for the CAZ group, while those on the fifth day were 87.9% (174/198) for the T-3762 group and 90.7% (196/216) for the CAZ group, showing no significant difference between the two groups. Although side effects were observed in 2.8% (4/145) of the patients in the T-3762 group and in 3.3% (5/152) of those in the CAZ group, these were all mild or moderate. Although abnormal clinical findings were observed in 11.2% (15/134) of the patients in the T-3762 group and in 18.8% (27/144) of those in the CAZ group, none were contributory. The overall safety rates (ratio of patients with 'safe' rating given by physician in charge) were 85.9% (116/135) for the T-3762 group and 77.6% (111/143) for the CAZ group, showing no significant difference between the two groups. The usefulness rates, determined in consideration of clinical efficacy and overall safety, were 85.2% (92/108) for the T-3762 group and 87.1% (101/116) for the CAZ group, showing no significant difference between the two groups. Judging from these findings, it is concluded that T-3762, a new quinolone drug, can be safely used with high clinical efficacy for injection in the treatment of complicated urinary tract infections.