Efficacy and safety of levofloxacin in patients with bacterial pneumonia evaluated according to the new "Clinical Evaluation Methods for New Antimicrobial Agents to Treat Respiratory Infections (Second Version)".
The guideline for the "Clinical Evaluation Methods for New Antimicrobial Agents to Treat Respiratory Infections (Second Version)," published by the Japanese Society of Chemotherapy in January 2012, was proposed to achieve consistency with FDA guidelines based on the concept of clinical evaluation used in Japan. We assessed the clinical efficacy of levofloxacin (LVFX) in patients with bacterial pneumonia according to this new set of guidelines for the first time. The clinical efficacy of LVFX in patients with community-acquired pneumonia (CAP) and healthcare-associated pneumonia (HCAP) at the test of cure (TOC) was 87.5% (56/64) and 85.7% (6/7), respectively, with an overall efficacy of 87.3% (62/71). The clinical efficacy of LVFX at TOC was as follows: intravenous 81.5% (22/27), oral 88.9% (24/27), switchover from intravenous to oral administration 100% (10/10), respectively. The bacterial eradication rate in the patients with CAP and HCAP and overall efficacy at the end of therapy (EOT) was 95.3% (41/43), 100.0% (4/4) and 95.7% (45/47), respectively. The frequent causative bacterial strains included Streptococcus pneumoniae (18), Haemophilus influenzae (14) and Moraxella catarrhalis (6). The incidence of adverse reactions in the patients whose safety was evaluated was 15.7% (14/89), similar to that previously reported. The clinical efficacy of LVFX at the early phase, EOT and TOC of CAP, as assessed according to the new and former guidelines, was 70.4% (38/54) and 27.8% (15/54), 87.0% (60/69) and 79.1% (53/67), 87.5% (56/64) and 88.1% (59/67), respectively, with no significant differences. Therefore, the new efficacy evaluation method can be used in exchange for the former evaluation method.
Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. Electronic address: hmukae@med.uoeh-u.ac.jp.
Hiroshi
H
Mukae
Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
Toshinori
T
Kawanami
Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
Kazuhiro
K
Yatera
Department of Clinical Laboratory, Nagasaki University Hospital, Nagasaki, Japan.
Katsunori
K
Yanagihara
Department of Molecular Microbiology and Immunology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
Yoshihiro
Y
Yamamoto
Department of Molecular Microbiology and Immunology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
Hiroshi
H
Kakeya
Department of Respiratory Medicine and Infectious Diseases, Oita University Faculty of Medicine, Oita, Japan.
Issei
I
Tokimatsu
Department of Respiratory Medicine and Infectious Diseases, Oita University Faculty of Medicine, Oita, Japan.
Junichi
J
Kadota
Department of Molecular Microbiology and Immunology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
Shigeru
S
Kohno
D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan; D064704:Levofloxacin / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D011446:Prospective Studies
D000890:Anti-Infective Agents; D064704:Levofloxacin
Clinical study; Community-acquired pneumonia; General guidelines for the evaluation of new antimicrobial agents; Levofloxacin; Respiratory tract infection