[Study of finding the optimum dose of cefetamet pivoxil in complicated urinary tract infections].

To find the optimum dose of cefetamet pivoxil (CEMT-PI, Ro 15-8075), a new oral cephem, in the treatment of complicated urinary tract infections, we performed a randomized trial using cefaclor (CCL) as the control drug. The subjects were patients with complicated urinary tract infections associated with underlying urinary tract diseases. Patients with indwelling catheter were excluded from the analysis, as were patients with infection due to Pseudomonas aeruginosa. Patients were treated with 250 mg of CEMT-PI (CEMT-PI-L) 2 times a day, 500 mg of CEMT-PI (CEMT-PI-H)2 times a day or 500 mg of CCL 3 times a day for 7 days. The overall clinical efficacy was evaluated on the basis of the criteria proposed by the Japanese UTI Committee. Of the 103 patients evaluated for clinical efficacy, 36 patients received CEMT-PI-L, 37 patients received CEMT-PI-H and 30 patients received CCL. No significant difference in background characteristics was observed among the three treatment groups. The overall clinical efficacies at day 3 judgement were 67.9% in 28 patients treated with CEMT-PI-L, 60.0% in 30 patients treated with CEMT-PI-H and 72.0% in 25 patients treated with CCL, with no statistically significant difference. Those at day 7 judgement was 63.6% in 33 patients treated with CEMT-PI-L, 66.7% in 36 patients treated with CEMT-PI-H and 72.4% in 29 patients treated with CCL, with no statistically significant difference. The bacteriological eradication rates at day 3 judgement were 79.5% of 39 strains in the CEMT-PI-L group, 73.2% of 41 strains in the CEMT-PI-H group and 84.4% of 32 strains in the CCL group, with no statistically significant difference. Those at day 7 judgement was 78.7% of 47 strains in the CEMT-PI-L group, 85.5% of 55 strains in the CEMT-PI-H group and 94.9% of 39 strains in the CCL group, with no statistically significant difference. The overall clinical efficacy and bacteriological eradication rate at day 7 judgement for CEMT-PI-H were higher than those for CEMT-PI-L. Clinical adverse reactions were observed in one patient in each of the 3 groups, but no statistically significant difference was found. We have concluded that the optimum daily dose of CEMT-PI in the treatment of complicated urinary tract infection is 1,000 mg.