Clinical phase II study of garenoxacin in patients with respiratory tract infections: Open-label, multi-center, non-comparative

Hiroyuki Kobayashi, Akira Watanabe, Nobuki Aoki, Shigeki Odagiri, Yasuyuki Sano, Atsushi Saito

    Research output: Contribution to journalArticle

    4 Citations (Scopus)

    Abstract

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

    Original languageEnglish
    Pages (from-to)116-126
    Number of pages11
    JournalJapanese Journal of Chemotherapy
    Volume55
    Issue numberSUPPL. 1
    Publication statusPublished - 2007 Oct 1

    Keywords

    • Clinical study
    • Des-fluoro(6)-quinolone
    • Garenoxacin
    • Respiratory infection

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

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    Kobayashi, H., Watanabe, A., Aoki, N., Odagiri, S., Sano, Y., & Saito, A. (2007). Clinical phase II study of garenoxacin in patients with respiratory tract infections: Open-label, multi-center, non-comparative. Japanese Journal of Chemotherapy, 55(SUPPL. 1), 116-126.