Vol.56 No.S-1 April 2008
Comparative study on sitafloxacin and levofloxacin in complicated urinary tract infections
1)Gifu University School of Medicine, 1-1 Yanagido, Gifu, Japan
2)Department of Urology, Kizawa Memorial Hospital
3)Department of Urology, Kobe Red Cross Hospital
4)Department of Urology, Okayama Citizens' Hospital
5)Department of Urology, University of Occupational and Environmental Health
6)Division of Anaerobe Research, Life Science Research Center, Gifu University
7)Hamamatsu Institute of Clinical Pharmacology and Therapeutics
Abstract
The clinical efficacy and safety of sitafloxacin(STFX), a fluoroquinolone compound, in complicated urinary tract infections(UTI) was investigated in a randomized double-blind comparative study using levofloxacin(LVFX) as a control.
Patients with complicated UTI without indwelling catheters were treated orally 7 days with 50 mg b.i.d. of STFX or 100 mg t.i.d. of LVFX. Clinical efficacy was evaluated based on criteria for evaluation of clinical efficacy of antimicrobial agents on urinary tract infection (third edition).
Patients evaluated numbered 200. Overall clinical efficacy was 96.1% (98/102) in the STFX group and 82.7% (81/98) in the LVFX group. The difference in efficacy was 13.4% and the minimum 90% confidence interval was 6.4%. The noninferiority of STFX efficacy was evaluated against that of LVFX. Strains isolated before dosing numbered 280. Overall microbiological eradication was 96.4% (132/137) in the STFX group and 86.0% (123/143) in the LVFX group. Eradication in the STFX group was significantly higher than that in the LVFX group.
The incidence of adverse reactions was 24.6% (30/122) in the STFX group and 11.6% (14/121) in the LVFX group. The incidence in the STFX group was significantly higher than that in the LVFX group. (χ2 test: p=0.008). The most common adverse reaction was diarrhea in both groups. All symptoms were mild or moderate.
Results suggest that 50 mg b.i.d. of STFX is effective and without significant safety problems in the treatment of complicated UTI.
Key word
sitafloxacin, levofloxacin, complicated urinary tract infections, double blind study
Received
October 18, 2007
Accepted
December 18, 2007
Jpn. J. Chemother. 56 (S-1): 81-91, 2008
