Iwanaga Naoki, Hosogaya Naoki, Takazono Takahiro, Tsukamoto Yusei, Morio Ryosuke, Irifune Satoshi, Miyamura Takuto, Harada Yosuke, Nagayoshi Yohsuke, Kondo Akira, Mihara Tomo, Kohno Yoshihisa, Fukuda Yuichi, Kobayashi Tsutomu, Sasaki Eisuke, Sawai Toyomitsu, Imamura Yoshifumi, Morikawa Toru, Hashiguchi Kohji, Futsuki Yoji, Inoue Yuichi, Fukushima Kiyoyasu, Suyama Naofumi, Senju Hiroaki, Tanaka Hikaru, Kawazoe Yurika, Morimoto Shimpei, Ito Yuya, Yoshida Masataka, Takeda Kazuaki, Ide Shotaro, Sakamoto Noriho, Izumikawa Koichi, Yanagihara Katsunori, Mukae Hiroshi
Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, JPN.
Clinical Research Center, Nagasaki University Hospital, Nagasaki, JPN.
Cureus. 2025 Mar 11;17(3):e80404. doi: 10.7759/cureus.80404. eCollection 2025 Mar.
For treating community-acquired pneumonia (CAP) in adults, early switching from injectable to oral antimicrobials (switch therapy) is accepted once the clinical course is favorable. Lascufloxacin (LSFX) is a quinolone antibacterial agent, available in intravenous and oral formulations, demonstrating antibacterial activity against a relatively broad spectrum of community-onset pneumonia (COP). No switch therapy using the same drug from injectable to oral antimicrobials has been reported; therefore, we conducted the study to confirm the efficacy and safety of the switch therapy using LSFX.
We conducted an open-label, uncontrolled, multicenter study across 16 hospitals from April 2023 to February 2024 to evaluate the efficacy and safety of LSFX switch therapy against mild-to-moderate COP. Once the switch criteria were fulfilled on days 3-5, switch therapy was initiated. The primary endpoint was the cure rate at the time of test of cure (TOC). Secondary endpoints included the proportion of patients receiving switch therapy, clinical efficacy at the end of treatment (EOT), early clinical response, microbiological response at the EOT, and adverse events. The adverse events were collected from the population for the safety analysis set.
The median age of the participants was 73 years, and the overall switch therapy implementation rate was 114/120 (95%), aligned with approximately 99/104 (95%) of the switch therapy performed by day three after initiating the therapy. The cure or effective rate was 100/104 (96.2%, 95% confidence interval (CI): 90.44-98.94) at TOC, 101/104 (97.1%, 95% CI: 91.80-99.40) at the early clinical efficacy testing, and 103/104 (99.0%, 95% CI: 94.76-99.98) at EOT. Adverse events related to the study drug were reported in 10.0% of the patients, with hepatic dysfunction as the most common adverse effect. Severe LSFX-induced adverse events were not observed, excluding worsening pneumonia.
Switch therapy using LSFX presented high efficacy and acceptable safety profiles against mild-to-moderate severity of COP. This strategy of using the same drug in both intravenous and oral formulations is quite innovative. LSFX may potentially emerge as one of the preferred options for treating COP.
在治疗成人社区获得性肺炎（CAP）时，一旦临床病程进展顺利，从注射用抗菌药物转换为口服抗菌药物（转换疗法）是被认可的。拉斯氟沙星（LSFX）是一种喹诺酮类抗菌剂，有静脉注射和口服两种剂型，对较广泛的社区起病性肺炎（COP）具有抗菌活性。尚未有关于使用同一种药物从注射剂转换为口服抗菌药物的转换疗法的报道；因此，我们开展了本研究以确认使用LSFX进行转换疗法的疗效和安全性。
我们于2023年4月至2024年2月在16家医院进行了一项开放标签、非对照、多中心研究，以评估LSFX转换疗法治疗轻至中度COP的疗效和安全性。一旦在第3至5天满足转换标准，即开始转换疗法。主要终点是治愈测试（TOC）时的治愈率。次要终点包括接受转换疗法的患者比例、治疗结束时（EOT）的临床疗效、早期临床反应、EOT时的微生物学反应以及不良事件。不良事件从用于安全性分析集的人群中收集。
参与者的中位年龄为73岁，总体转换疗法实施率为114/120（95%），与治疗开始后第三天进行的转换疗法中约99/104（95%）相符。TOC时的治愈或有效率为100/104（96.2%，95%置信区间（CI）：90.44 - 98.94），早期临床疗效测试时为101/104（97.1%，95% CI：91.80 - 99.40），EOT时为1 /104（99.0%，95% CI：94.76 - 99.98）。10.0%的患者报告了与研究药物相关的不良事件，肝功能障碍是最常见的不良反应。未观察到严重的LSFX诱导的不良事件，不包括肺炎病情恶化。
使用LSFX进行转换疗法在治疗轻至中度严重程度的COP方面显示出高疗效和可接受的安全性。这种在静脉注射和口服制剂中使用同一种药物的策略颇具创新性。LSFX可能会成为治疗COP的首选药物之一。
