Dose-Finding Study of Gatifloxacin in Complicated Urinary Tract Infections

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  • 複雑性尿路感染症に対するgatifloxacinの用量設定試験

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Abstract

A dose-finding clinical trial, a double-blind, randomized, comparative study of gatifloxacin (GFLX), a new oral 8-methoxyquinolone derivative antimicrobial agent, was performed to determine the optimal dosage in complicated urinary tract infections.<BR>100mg, 150mg, and 200mg of GFLX b. i. d. for 7 days (called L, M, and H groups, respectively) were administered to 143 patients who had no indwelling catheters.Clinical efficacy was evaluated according to the criteria of the Japanese UTI Committee, and the following results were obtained:<BR>1. The number of patients evaluated for clinical efficacy was 37, 39, and 37 in L, M, and H groups, respectively.Among the three groups, there was no significant difference in background characteristics of patients.<BR>2. Overall clinical efficacy rates were obtained in 86.5% of 37 patients in L group, 82.1% of 39 patients in M group, and 94.6% of 37 patients in H group. These differences were not statistically significant.<BR>3. Overall bacteriological eradication rates obtained in L, M, and H groups were 90.7 % of 54 strains, 90.3% of 62 strains, and 96.4% of 55 strains, respectively, with no significant differences.<BR>4. Incidence of clinical adverse reactions in L, M, and H groups were 2.1%(1/48 patients), 6.5%(3/46), and 2.1%(1/48), and of laboratory adverse reactions, 4.5%(2/44), 2.2%(1/45), and 2.3%(1/44), respectively, the differences being not significant.None of the findings in adverse reactions were serious.<BR>5. There was also no significant difference in clinical value among the three groups.<BR>From the results of this study, we conclude that 200 mg b.i.d.of GFLX is the optimal dosage for treatment of complicated urinary tract infections.

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