Comparative study on FK 037 and ceftazidime in complicated urinary tract infection

Abstract

A comparative study of FK 037, a new parenteral cephem antibiotic, and ceftazidime (CAZ) was carried out in the treatment of complicated urinary tract infection. Patients were randomly assigned to receive either 1g b. i. d. of FK 037 or CAZ for 5 days by intravenous drip infusion. All the patients were found to have pyuria of at least 5 WBCs per high power field, bacteriuria of at least 10⁴CFU per ml of urine and identifiable underlying urinary tract disease. Overall clinical efficacy was evaluated on the basis of criteria proposed by the Japanese UTI Committee as “excellent”, “moderate” and “poor”. Of the 223 patients enrolled in the study, 178 patients were evaluated for clinical efficacy. No significant differences were observed in the characteristics of the patients evaluated for clinical efficacy between the two treatment groups. Excellent and moderate responses were obtained in 89.3% of 84 patients in the FK 037 group and in 83.0% of 94 patients in the CAZ group. The difference was not statistically significant. The bacteriological eradication rate was 93.0% of 157 strains in the FK 037 group and 87.8% of 181 strains in the CAZ group, with no statistically significant difference. Clinical adverse reactions were experienced in 1 (0.9%) of 110 patients in the FK 037 group and in 2 (1.8%) of 113 patients in the CAZ group. Laboratory adverse reactions were observed in 3 (2.8%) of 107 patients in the FK 037 group and in 11 (9.8%) of 112 patients in the CAZ group, with no statistically significant difference regarding the incidences of either clinical or laboratory adverse reactions. However, both global safety and clinical value were found to be higher in the FK 037 group than in the CAZ group (p<0.05). We concluded that FK 037 is as effective as and better tolerated than CAZ in the treatment of complicated urinary tract infection.