Vol.69 No.3 May 2021

Open-label study of intravenous lascufloxacin for secondary infections in patients with chronic pulmonary diseases, aspiration pneumonia and lung abscess

Makoto Miki¹⁾, Keiichi Mikasa²⁾, Junichi Kadota³⁾, Hiroshi Mukae⁴⁾, Jiro Fujita⁵⁾, Katsunori Yanagihara⁶⁾, Kazuhiro Tateda⁷⁾, Kyoichi Totsuka⁸⁾, Tomohiko Eiraku⁹⁾ and Shigeru Kohno¹⁰⁾

¹⁾Department of Respiratory Medicine, Japanese Red Cross Sendai Hospital, 2-43-3 Yagiyamahoncho, Taihaku-ku, Sendai, Miyagi, Japan
²⁾Nara Koseikai Hospital
(Past: Center for Infectious Diseases, Nara Medical University)
³⁾Nagasaki Harbor Medical Center
(Past: Oita University Hospital)
⁴⁾Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences
⁵⁾Department of Infectious, Respiratory, and Digestive Medicine, Graduate School of Medicine, University of the Ryukyus
⁶⁾Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences
⁷⁾Department of Microbiology and Infectious Disease, Toho University School of Medicine
⁸⁾Department of Internal Medicine, Kita-tama Hospital
⁹⁾Clinical Development Center, Kyorin Pharmaceutical
¹⁰⁾Nagasaki University

Abstract

To investigate the efficacy and safety of intravenous lascufloxacin (LSFX) for secondary infections in patients with chronic pulmonary diseases, aspiration pneumonia and lung abscess, we conducted this multicenter, open-label, non-comparative study. The subjects were administered LSFX 150 mg (300 mg on day 1) by intravenous injection once daily for 7 to 14 days.
Clinical efficacy: For secondary infections in patients with chronic pulmonary diseases, the cure rate at test-of-cure, as the primary endpoint, was 93.3% (42/45). In regard to the secondary endpoints, the clinical efficacy rates on Day 3 and at end-of-treatment (EOT) were 87.0% (40/46) and 97.8% (45/46), respectively. In patients with aspiration pneumonia and lung abscess, the clinical efficacy rates at EOT, as the primary endpoint, were 100% (12/12) and 90.9% (10/11), respectively, and the clinical efficacy rates on Day 3, as the secondary endpoint, were 92.3% (12/13) and 81.8% (9/11), respectively.
Microbiological outcome: The bacterial eradication rates by subject were 95.2% (20/21) in patients with chronic pulmonary diseases presenting with secondary infections, 91.7% (11/12) for aspiration pneumonia, and 90.9% (10/11) for lung abscess.
Safety: The incidence rates of adverse events and adverse drug reactions were 64.1% (50/78) and 33.3% (26/78), respectively. There were no deaths in this study. One patient developed lung disorder as a serious adverse drug reaction, but full recovery was observed with medication and other supportive treatments.
Based on the results, intravenous administration of LSFX 150 mg (300 mg on day 1) once daily may be expected to show high efficacy, with no major safety problems, in patients with chronic pulmonary diseases presenting with secondary infections, patients with aspiration pneumonia, and patients with lung abscess.

Key word

lascufloxacin, secondary infection, chronic respiratory disease, aspiration pneumonia, lung abscess

Received

October 5, 2020

Accepted

January 12, 2021

Jpn. J. Chemother. 69 (3): 270-285, 2021