Vol.55 No.S-1 October 2007
Clinical phase III comparative study on garenoxacin versus levofloxacin in patients with bacterial pneumonia
1)Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo, Japan
2)Department of Respiratory Medicine, Division of Cancer Control, Institute of Development, Aging and Cancer, Tohoku University
(Present: Reserch Division for Development of Anti-Infective Agents, Institute of Development, Aging and Cancer, Tohoku University)
3)Department of Internal Medicine, Shinrakuen Hospital
4)Odagiri Respiratory Disease Clinic
5)First Department of Internal Medicine, Kyorin University School of Medicine
(Present: Department of Infectious Disease, Kyorin University School of Medicine)
6)Division of Respiratory Diseases, Department of Internal Medicine, Kawasaki Medical School
(Present: Department of Clinical Infectious Diseases, School of Medicine, Showa University)
7)Second Department of Internal Medicine, Nagasaki University
(Present: Division of Molecular and Clinical Microbiology, Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences)
8)First Department of Internal Medicine, School of Medicine, University of Ryukyus
(Present: Japanese Red Cross Nagasaki Genbaku Isahaya Hospital)
Abstract
The clinical efficacy and safety of garenoxacin mesilate hydrate(GRNX), a novel des-fluoro quinolone, and levofloxacin (LVFX) for bacterial pneumonia were investigated double blind. Clinical efficacy was observed at the end day of treatment, and comparing the results of the 7th day after treatment completion in European and South American studies, patients were treated with either GRNX 400 mg once daily (GRNX group) or LVFX 100 mg three times daily (LVFX group) for 10 days.
The efficacy rates at the end day of treatment were 99.1% (111/112) in the GRNX group and 94.9% (82/87) in the LVFX group. The noninferiority of GRNX against LVFX was demonstrated. The efficacy rates at the 7th day after treatment completion were 94.9% (94/99) in the GRNX group and 92.8% (77/83) in the LVFX group. Bacteriological efficacy was 100% in both the GRNX group (59/59) and the LVFX group (40/40). The bacteriological eradication rates at the 7th day after treatment completion were 100% (50/50) in the GRNX group and 86.8% (33/38) in the LVFX group. The incidence of drug-induced adverse events, including laboratory abnormalities was 35.6% (48/135) in the GRNX group and 27.1% (32/118) in the LVFX group, indicating no significant difference between groups. The sort and grade of adverse events were also similar between groups, and no strange event was observed.
The efficacy rate of GRNX at the 7th day after treatment completion was 89.9% (89/99) in European and South American studies. The clinical efficacy and safety which were observed in our study were similar to those of overseas results.
Summarizing this study, GRNX, a 400 mg oral dose once daily for 10 days, should be clinically a very useful medication in the treatment of bacterial pneumonia.
Key word
garenoxacin, pneumonia, double blind study, levofloxacin
Received
June 8, 2007
Accepted
July 18, 2007
Jpn. J. Chemother. 55 (S-1): 127-143, 2007
