Vol.55 No.S-1 October 2007
Clinical phase III study of oral garenoxacin in patients with community-acquired acute respiratory infection
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: Research 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)Japanese Red Cross Nagasaki Genbaku Isahaya Hospital
Abstract
The clinical efficacy and safety of garenoxacin(GRNX), a novel des-fluoroquinolone, were observed in patients with respiratory tract infection including community-acquired pnuemonia and acute bronchitis caused by Mycoplasma pneumoniae, Chlamydia pneumoniae or Streptococcus pneumoniae, community organisms. All patients were treated with 400 mg once daily dose of GRNX for 7-10 days.
1. Clinical efficacy: The efficacy rate at the end day of treatment was 98.9% (88/89) in all cases of community-acquired pnuemonia, including pneumonia with M. pneumoniae 100% (20/20), with C. pneumoniae 92.3% (12/13) and with common bacterial organisms 100% (56/56). The efficacy rate for acute bronchitis was observed in 100% (13/13), including 12 cases with bacteria and 1 case with C. pneumoniae.
2. Bacteriological efficacy: The eradication rate at the end day of treatment was 81.8% (27/33) in all cases of community-acquired pnuemonia, including pneumonia with M. pneumoniae 6/6 and with common bacterial organisms 95.5% (21/22). The eradication rate for acute bronchitis was observed in 5/5.
Bacteriological response with 5 cases of mixed infection caused by bacteria, M. pneumoniae and C. pneumoniae was judged as partial eradication.
3. Safety: Adverse reactions involving 233 were observed in 93 cases of 144 cases (64.6%). Some 103 events of the side effects and drug induced laboratory abnormalities were observed in 55 out of 144 cases (38.2%). Abnormalities seen most frequently were increases in ALT and AST , but the incidence was 10.5% (15/143) in the former and 5.6% (8/143) in the latter.
From above findings of GRNX, a 400 mg oral dose once daily treatment may be useful for patients with respiratory tract infections including mycoplasma pneumonia, chlamydia pneumonia and acute bronchitis.
Key word
garenoxacin, respiratory tract infection, Mycoplasma pneumoniae, Chlamydia pneumoniae
Received
June 13, 2007
Accepted
July 25, 2007
Jpn. J. Chemother. 55 (S-1): 169-184, 2007
