Dose-comparative study of sitafloxacin in complicated urinary tract infections

  • Kawada Yukimichi
    Gifu University School of Medicine
  • Yasuda Mitsuru
    Department of Urology, Gifu University Graduate School of Medicine
  • Tanaka Kazushi
    Department of Urology, Kobe University Graduate School of Medicine
  • Monden Koichi
    Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
  • Akasaka Soichiro
    Department of Urology, University of Occupational and Environmental Health
  • Egashira Toshihisa
    Department of Urology, Kyushu University School of Medicine
  • Kaku Mitsuo
    Field of Infection Control and Laboratory Diagnostics, Internal Medicine, Tohoku University Graduate School of Medicine
  • Hori Seiji
    Department of Pharmacology, Jikei University School of Medicine

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  • 複雑性尿路感染症を対象としたsitafloxacinの用量比較試験

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Abstract

The clinically recommended dose of sitafloxacin (STFX), a fluoroquinolone compound, in complicated urinary<BR>tract infections (UTI) was investigated in a randomized double-blind study.<BR>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).<BR>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.<BR>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.

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