Phase III double-blind comparative study of sitafloxacin versus tosufloxacin in patients with community-acquired pneumonia

• Saito Atsushi

  Japanese Red Cross Nagasaki Genbaku Isahaya Hospital

• Watanabe Akira

  Research Division for Department of Anti-Infective Agents, Institute of Development, Aging and Cancer, Tohoku University

• Aoki Nobuki

  Department of Internal Medicine, Shinrakuen Hospital

• Niki Yoshihito

  Department of Clinical Infectious Diseases, School of Medicine, Showa University

• Kohno Shigeru

  Division of Molecular and Clinical Microbiology, Department of Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences

• 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

Bibliographic Information

Other Title

• 市中肺炎に対するSitafloxacinとtosufloxacinの第III相二重盲検比較試験

Abstract

Sitafloxacin (STFX), a fluoroquinolone antimicrobial agent, has potent antimicrobial activity against Streptococcus pneumoniae, the major pathogenic bacteria in respiratory tract infections. The clinical efficacy and safety of STFX and tosufloxacin (TFLX) were compared in the treatment patients with community-acquired pneumonia in a double-blind, randomized, group-comparative study. Patients were treated orally twice daily 7 days with either STFX at 100 mg (STFX group) or TFLX at 150 mg three times daily (TFLX group).<BR>Clinical efficacy in 225 patients was 93.3%(111/119 patients) in the STFX group and 89.6%(95/106 patients) in the TFLX group. STFX was found to be not inferior to TFLX. Bacteriological response in 93 patients was 100%(42/42 patients) in the STFX group and 88.2%(45/51 patients) in the TFLX group. Eradication of causative organisms in overall bacteriological response was 100%(48/48) in the STFX group and 91.1%(51/56) in the TFLX group. Eradication rate of S. pneumoniae was 100%(14/14) in the STFX group and 87.0%(20/23) in the TFLX group. The incidence of adverse drug reactions (ARs) was 48.4%(61/126 patients) in the STFX group and 40.5%(49/121 patients) in the TFLX group. No severe ARs were observed in either groups, indicating that STFX is well tolerated in the treatment of community-acquired pneumonia. Results suggest that a 50mg oral dose of STFX twice daily for 7 days is useful clinically in the treatment of community-acquired pneumonia.

Journal

• Japanese Journal of Chemotherapy

  Japanese Journal of Chemotherapy 56 (Supplement1), 49-62, 2008

  Japanese Society of Chemotherapy

Keywords

• community acquired pneumonia
• double blind study
• sitafloxacin
• tosufloxacin
• fluoroquinolone

Details

• CRID: 1390282681264803968
• NII Article ID: 10021192799
• NII Article ID: 130004102788
• NII Book ID: AN10472127
• DOI: 10.11250/chemotherapy1995.56.supplement1_49
• ISSN: 18845886
• ISSN: 13407007
• Web Site: https://search.jamas.or.jp/link/ui/2008207509
• Text Lang: ja
• Data Source:
  • JaLC
  • CiNii Articles
• Abstract License Flag: Disallowed