Comparative study on sitafloxacin and levofloxacin in complicated urinary tract infections

• Kawada Yukimichi

  Gifu University School of Medicine

• Ishihara Satoshi

  Department of Urology, Kizawa Memorial Hospital

• Matsui Takashi

  Department of Urology, Kobe Red Cross Hospital

• Tsugawa Masaya

  Department of Urology, Okayama Citizens' Hospital

• Matsumoto Tetsuro

  Department of Urology, University of Occupational and Environmental Health

• Watanabe Kunitomo

  Division of Anaerobe Research, Life Science Research Center, Gifu University

• Nakashima Mitsuyoshi

  Hamamatsu Institute of Clinical Pharmacology and Therapeutics

Bibliographic Information

Other Title

• 複雑性尿路感染症を対象としたsitafloxacinとlevofloxacinの二重盲検比較試験

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.<BR>Patients with complicated UTI without indwelling catheters were treated orally 7 days with 50mg b.i.d. of STFX or 100 mg t.i.d. of LVFX. Clinical efficacy was evaluated based on criteria for evaluation ofclinical efficacy of antimicrobial agents on urinary tract infection (third edition).<BR>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.<BR>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.(X²test: p=0.008). The most common adverse reaction was diarrhea in both groups. All symptoms were mild or moderate.<BR>Results suggest that 50mg b.i.d. of STFX is effective and without significant safety problems in the treatment of complicated UTI.

Journal

• Japanese Journal of Chemotherapy

  Japanese Journal of Chemotherapy 56 (Supplement1), 81-91, 2008

  Japanese Society of Chemotherapy

Keywords

• sitafloxacin
• levofloxacin
• complicated urinary tract infections
• double blind study

Details

• CRID: 1390282681264793216
• NII Article ID: 10021192838
• NII Article ID: 130004102790
• NII Book ID: AN10472127
• DOI: 10.11250/chemotherapy1995.56.supplement1_81
• ISSN: 18845886
• ISSN: 13407007
• Web Site: https://search.jamas.or.jp/link/ui/2008207511
• Text Lang: ja
• Data Source:
  • JaLC
  • CiNii Articles
• Abstract License Flag: Disallowed