Efficacy and safety of lascufloxacin for nursing- and healthcare-associated pneumonia: A single-arm, open-label clinical trial
Year: 2024
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Nursing- and healthcare-associated pneumonia (NHCAP) constitutes most of the pneumonia in elderly patients including aspiration pneumonia in Japan. Lascufloxacin (LSFX) possesses broad antibacterial activity against respiratory pathogens, such as Streptococcus spp. And anaerobes inside the oral cavity. However, the efficacy and safety of LSFX in NHCAP treatment remains unknown. We aimed to evaluate the efficacy and safety of LSFX tablets in the treatment of patients with NHCAP. METHODS: In this single-arm, open-label, uncontrolled study, LSFX was administered to patients with NHCAP at 24 facilities. The study participants were orally administered 75 mg LSFX once daily for 7 days. The primary endpoint was the clinical efficacy at the time of test of cure (TOC). The secondary endpoints included clinical efficacy at the time of end of treatment (EOT), early clinical efficacy, microbiological efficacy, and safety analysis. RESULT: During the study period, 75 patients provided written informed consent to participate and were included. Finally, 56 and 71 patients were eligible for clinical efficacy and safety analyses, respectively. The median age of the patients was significantly high at 86 years. All patients were classified as having moderate disease severity using the A-DROP scoring system. LSFX tablets demonstrated high efficacy rates of 78.6 % at TOC and 89.3 % at EOT. The risk factors for resistant bacteria or aspiration pneumonia did not affect clinical efficacy. No severe adverse events associated with the study drugs were observed. CONCLUSION: Oral LSFX is an acceptable treatment option for moderate NHCAP in elderly patients who can take oral medications.
Authors: Takahiro Takazono, Naoki Hosogaya, Koki Fukushima, Ryosuke Morio, Satoshi Irifune, Takuto Miyamura, Yosuke Harada, Yosuke Nagayoshi, Akira Kondo, Tomo Mihara, Yuichi Fukuda, Eisuke Sasaki, Toyomitsu Sawai, Yoshifumi Imamura, Toru Morikawa, Yoji Futsuki, Yuichi Inoue, Kiyoyasu Fukushima, Naofumi Suyama, Hikaru Tanaka, Tetsuya Hanaka, Ikuko Shimabukuro, Ryosuke Hata, Kenji Ota, Shimpei Morimoto, Nana Nakada, Yuya Ito, Masataka Yoshida, Kazuaki Takeda, Shotaro Ide, Naoki Iwanaga, Kazuki Nemoto, Midori Funada, Koichi Izumikawa, Kazuhiro Yatera, Katsunori Yanagihara, Hiroshi Mukae
Institutions: Nagasaki University Hospital, Nagasaki University, Japanese Red Cross Nagasaki Genbaku Isahaya Hospital, Japanese Red Cross Nagasaki Genbaku Hospital, Japan Community Healthcare Organization, Isahaya General Hospital, Sasebo City General Hospital, Ureshino Medical Center, Nagasaki Medical Center, Nagasaki Memorial Hospital, University of Occupational and Environmental Health Japan, Hospital of the University of Occupational and Environmental Health, Wakamatsu Hospital of the University of Occupational and Environmental Health, Japan
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $2,650
Funder: Kyorin Pharmaceutical
OpenAlex ID: W4390636072