Vol.56 No.S-1 April 2008
Dose-comparative study of sitafloxacin in complicated urinary tract infections
1)Gifu University School of Medicine, 1-1 Yanagido, Gifu, Japan
2)Department of Urology, Gifu University Graduate School of Medicine
3)Department of Urology, Kobe University Graduate School of Medicine
4)Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
5)Department of Urology, University of Occupational and Environmental Health
6)Department of Urology, Kyushu University School of Medicine
7)Field of Infection Control and Laboratory Diagnostics, Internal Medicine, Tohoku University Graduate School of Medicine
8)Department of Pharmacology, Jikei University School of Medicine
Abstract
The clinically recommended dose of sitafloxacin(STFX), a fluoroquinolone compound, in complicated urinary tract infections(UTI) was investigated in a randomized double-blind study.
Patients with complicated UTI without indwelling catheters were treated for 7 days with either 50 mg b.i.d. (group L) or 100 mg b.i.d.(group H) of oral STFX. Clinical efficacy was evaluated based on criteria for evaluation of clinical efficacy of antimicrobial agents on urinary tract infection (draft, fourth edition).
Patients numbered 196 and overall clinical efficacy at the end of treatment was 91.0% (91/100) in group L and 96.9% (93/96) in group H. Strains isolated before dosing numbered 302 and overall microbiological eradication was 93.5% (145/155) in group L and 96.6% (142/147) in group H. Eradication for microbiological outcome at 5 to 9 days after the end of treatment was 56.3% (54/96) in group L and 63.4% (59/93) in group H. Eradication for microbiological outcome at 4 to 6 weeks after the end of treatment was 57.8% (26/45) in group L and 57.1% (32/56) in group H. The incidence of adverse reactions was 24.6% (32/130) in group L and 24.6% (31/126) in group H. The most common adverse reaction was diarrhea, with an incidence slightly higher in group H than group L. All symptoms were mild or moderate.
Results suggest that 50 mg b.i.d. of STFX is a reasonable recommended dose with good clinical efficacy and tolerability in the treatment of complicated UTI.
Key word
sitafloxacin, dose finding study, complicated urinary tract infection, double blind study
Received
October 11, 2007
Accepted
December 18, 2007
Jpn. J. Chemother. 56 (S-1): 92-102, 2008
