Open study of sitafloxacin in patients with respiratory tract infections

• Saito Atsushi

  Japanese Red Cross Nagasaki Genbaku Isahaya Hospital

• Tanigawara Yusuke

  Keio University School of Medicine

• 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

• Totsuka Kyoichi

  Department of Infectious Diseases, Tokyo Women's Medical University

Bibliographic Information

Other Title

• 呼吸器感染症に対するsitafloxacinの一般臨床試験
• 知識資本主義における貧困化の構図
• チシキ シホン シュギ ニ オケル ヒンコンカ ノ コウズ
• PK/PD study

Abstract

Sitafloxacin (STFX), a fluoroquinolone antimicrobial agent, has a broad spectrum ofactivity and a potent antimicrobial activity against Streptococcus pneumoniae which is a major pathogen in respiratory tract infections (RTI). This clinical study was conducted to confirm the clinical recommended dose of STFX as 50mg b.i.d. for RTI from PK/PD.<BR>Clinical efficacy was 92.3%(96/104) in the 50mg b.i.d. group and 93.1%(27/29) in the 100 mg bid. group. Bacteriological efficacy was 89.1%(57/64) in the 50mg b.i.d. group and 82.4%(14/17) in the 100mg bid. group. Eradication of major causative organisms was 91.7%(22/24) in S.pneumoniae and 100%(24/24) in Haemophilus influenzae.<BR>Steady state C_max and AUC_0-24h after repeated oral administration of STFX to patients with RTI were 0.57±0.21μg/mL and 9.38±4.24μg·h/mL in the 50mg b.i.d. group, and 1.17±0.45μg/mL and 17.16±6.52μg·h/mL in the 100 mg b.i.d. group.<BR>If C_max/MIC was 5 or below, or AUC_0-24h/MIC was 100 or below, eradication were 33.3%(3/9) or 40.0%(4/10).In contrast, if Cmax/MIC was over 5, it was 96.3%(79/82). If AUC_0-24h/MIC wasover 100, it was 96.3%(78/81).MIC₉₀ of STFX against the causative organisms in this study was 0.1μg/mL. Results suggest that 50mg b.i.d. of STFX can achieve C_max/MIC 5 and AUC_0-24h/MIC 100 against 90% of the causative organisms in RTI.<BR>Adverse drug reactions (ADR) occurred in 43.5%(50/115 patients) in the 50mg b.i.d. group and 42.4%(14/33 patients) in the 100mg b.i.d. group. The major ADR was diarrhoea (20/148, 13.5%). C_max and AUC_0-24h of patientsin whom diarrhoea or soft stool occurred tended to be higher than in patients free of these symptoms. No severe ADRs were observed in either groups.<BR>Results suggest that a dose of 50mg b.i.d. of STFX is optimal in the treatment of RTI.

Journal

• Japanese Journal of Chemotherapy

  Japanese Journal of Chemotherapy 56 (Supplement1), 63-80, 2008

  Japanese Society of Chemotherapy

Keywords

• respiratory tract infection
• PK/PD
• sitafloxacin
• fluoroquinolone

Details

• CRID: 1390282681264794880
• NII Article ID: 110007007450
• NII Article ID: 10021192816
• NII Article ID: 130004102789
• NII Book ID: AN10407566
• ISSN: 13417843
• ISSN: 18845886
• ISSN: 13407007
• DOI: 10.11250/chemotherapy1995.56.supplement1_63
• NDL BIB ID: 10199452
• Web Site: http://id.nii.ac.jp/1114/00001761/
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I10199452
• Web Site: https://search.jamas.or.jp/link/ui/2008207510
• Text Lang: ja
• Data Source:
  • JaLC
  • IRDB
  • NDL
  • CiNii Articles
  • KAKEN
• Abstract License Flag: Disallowed