Preliminary Report,on DU-6859a for Urinary Tract Infection

Abstract

The efficacy safety, and clinical value of DU-6859a, a novel new quinolone antimicrobial, were evaluated in a multicenter study. The subjects were selected from among patients aged 20 to 79 years with mild to moderate uncomplicated or complicated urinary tract infection (UTI). DU-6859a was administered orally after meals at a dose of 50–100 mg once or twice daily for 3–7 days. The clinical efficacy rate for all target infections was determined to be 88.5%, (100/113) by the attending physicians. The efficacy rate was 100% (21/21) for acute uncomplicated cystitis, 84.9% (62/73) for complicated cystitis, and 88.9% (16/18) for complicated pyelonephritis. The overall clinical efficacy rate and the eradication rate for urinary pathogens were determined according to the Criteria for Evaluation of Clinical Efficacy of Antimicrobial Agents for UTI proposed by the Japanese UTI Committee. The rates were, respectively, 100% (9/9) and 100% (11/11) for acute uncomplicated UTI and 88.0% (66/75) and 91.2% (93/102) for complicated UTI. Clinical adverse reactions were experienced in seven (5/7%) out of 123 evaluable patients, but all symptoms were mild. Laboratory adverse reactions, such as slight elevations of GOT and/or GPT, were noted in 13 (12.1%) out of 107 evaluable patients. DU-6859a showed excellent clinical efficacy against acute uncomplicated and complicated UTI which reflected its high antibacterial activity in vitro and did not cause any clinically significant adverse reactions. These results show that DU-6859a is worthy of further clinical studies for the treatment of UTI.