• Medicine · Feb 2023

    Evaluation of efficacy and safety of lascufloxacin for nursing and healthcare associated pneumonia: single-arm, open-label clinical trial: A study protocol.

    • Naoki Hosogaya, Takahiro Takazono, Kenji Ota, Rieko Kiya, Yumi Shirai, Rina Kawasaki, Hiroshi Yano, Shinpei Morimoto, Rumiko Nakao, Yumiko Kanamaru, Yukari Yoshino, Yasuyuki Ishikawa, Chizu Fukushima, Hiroshi Yamamoto, Koichi Izumikawa, Katsunori Yanagihara, and Hiroshi Mukae.
    • Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.
    • Medicine (Baltimore). 2023 Feb 22; 102 (8): e33092e33092.

    BackgroundLascufloxacin hydrochloride (LSFX) is a quinolone antibiotic that inhibits DNA gyrase and topoisomerase IV of bacteria, it is anticipated to minimize antibiotic resistance in bacteria. It exhibits antibacterial activity against a relatively wide range of bacterial species, including anaerobic bacteria, and its efficacy and safety against community-acquired pneumonia have been shown; however, its efficacy and safety against nursing and healthcare associated pneumonia (NHCAP) have not been verified.Methods/DesignHere, a single-arm, open-label, uncontrolled study was conducted in which LSFX was administered to patients with NHCAP at 24 facilities. The research subjects (77 cases) were orally administered 75 mg of LSFX once a day for 7 days. The primary endpoint was the clinical efficacy at the time of test of cure (TOC) (TOC; 5-10 days after the end of LSFX administration), while the secondary endpoints were the efficacy at the time of end of treatment, early clinical efficacy, microbiological efficacy at the time of TOC and end of treatment, and safety evaluation of LSFX.DiscussionNHCAP is a common pneumonia in clinical settings and a notable pneumonia whose mortality is high compared to community-acquired pneumonia. The present study showed the efficacy and safety of LSFX against NHCAP, which could lead to a larger number of therapeutic options for NHCAP.Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.

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