Vol.68 No.S-1 November 2020

Phase III double-blind comparative study of lascufloxacin versus levofloxacin in patients with community-acquired pneumonia

Makoto Miki¹⁾, Keiichi Mikasa²⁾, Junichi Kadota³⁾, Hiroshi Mukae⁴⁾, Jiro Fujita⁵⁾, Seiji Hori⁶⁾, Katsunori Yanagihara⁷⁾, Kazuhiro Tateda⁸⁾, Kyoichi Totsuka⁹⁾, Yasuko Umemoto¹⁰⁾ and Shigeru Kohno¹¹⁾

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⁾Oita University Hospital
⁴⁾Department of Respiratory Medicine, Unit of Basic Medical Sciences, 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 Infecion Control, Jikei University Hospital
⁷⁾Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences
⁸⁾Department of Microbiology and Infectious Disease, Toho University School of Medicine
⁹⁾Department of Internal Medicine, Kita-tama Hospital
¹⁰⁾Clinical Development Center, Kyorin Pharmaceutical
¹¹⁾Nagasaki University

Abstract

We conducted a phase III double-blind randomized comparative study to investigate the efficacy and safety of lascufloxacin (LSFX) as compared to levofloxacin (LVFX) in patients with community-acquired pneumonia (CAP). The subjects in the LSFX group received oral LSFX 75 mg once daily, and those in the LVFX group received oral LVFX 500 mg once daily. Both investigational drugs were administered for a period of 7 days.
The cure rate at test-of-cure, as the primary endpoint, was 92.8% (116/125) in the LSFX group and 92.3% (108/117) in the LVFX group, demonstrating the non-inferiority of LSFX 75 mg to LVFX 500 mg. The results for the secondary endpoints were as follows: the early clinical efficacy rate on Day 3 was 85.6% (107/125) in the LSFX group and 89.2% (107/120) in the LVFX group; the clinical efficacy rate at end-of-treatment was 96.0% (121/126) in the LSFX group and 95.8% (115/120) in the LVFX group. The bacterial eradication rate was 96.3% (26/27) in the LSFX group and 100.0% (33/33) in the LVFX group. Similar to LVFX, LSFX showed high clinical and microbiological effects, and is expected to exert excellent efficacy against both bacterial and atypical pneumonias, regardless of the causative microorganisms or prior treatment. The incidence of adverse events was 17.9% (25/140) in the LSFX group and 19.0% (26/137) in the LVFX group. No serious safety problems were noted with either drug.
Based on the results, oral administration of LSFX 75 mg once daily is expected to show high efficacy, with no major safety problems, in patients with CAP, including atypical pneumonia.

Key word

community-acquired pneumonia, lascufloxacin, levofloxacin, clinical trial

Received

October 30, 2019

Accepted

February 26, 2020

Jpn. J. Chemother. 68 (S-1): 41-54, 2020