Clinical phase II study of garenoxacin in patients with respiratory tract infections

DOI
  • Kobayashi Hiroyuki
    Kyorin University, School of Medicine
  • Watanabe Akira
    Department of Respiratory Medicine, Division of Cancer Control, Institute of Development, Aging and Cancer, Tohoku University
  • Aoki Nobuki
    Department of Internal Medicine, Shinrakuen Hospital
  • Odagiri Shigeki
    Department of Respiratory Diseases, Kanagawa Prefectural Cardiovascular and Respiratory Diseases Center Hospital
  • Sano Yasuyuki
    Department of Allergy and Respiratory Diseases, Douaikinen Hospital
  • Saito Atsushi
    First Department of Internal Medicine, School of Medicine, University of Ryukyus

Bibliographic Information

Other Title
  • 呼吸器感染症を対象としたgarenoxacinの臨床第II相試験
  • Open-label, multi-center, non-comparatlve
  • 非盲検・非対照・多施設試験

Abstract

The efficacy and safety of garenoxacin mesilate hydrate (GRNX), a des-F (6)-quinolone antibiotic, with 200 mg and 400mg administered once daily were evaluated in patients with respiratory tract infections. Plasma concentrations of garenoxacin were determined preliminarily.<BR>1. Clinical assessment: The efficacy rates were 96.0%(24/25) in 200mg group and 87.5%(21/24) in 400 mg group at the end of treatment. The efficacy rates at the 7th day of post-treatment were 100%(19/19) in 200mg group and 94.7%(18/19) in 400mg group.<BR>2. Bacteriological efficacy: The eradication rates were 100%(16/16) in 200mg group and 70.0%(7/10) in 400mg group at the end of treatment. The eradication rates at the 7th day of post-treatment were 100%(11/11) in 200mg group and 6/8 in 400mg group.<BR>3. Safety: The incidence of drug-related adverse events was 9.7%(3/31) in 200mg group and 6.5%(2/31) in 400mg group. The incidence of drug-related laboratory abnormality was 26.7%(8/30) in 200mg group and 19.4%(6/31) in 400mg group.<BR>4. Plasma concentration: The trough concentration of garenoxacin was 0.89±0.42μg/mL in 200mg group and 1.71±0.46μg/mL in 400mg group.<BR>Results indicate that a 400mg daily dose of GRNX gives a favorable prognosis in treatment for patients with respiratory tract infections.

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