Vol.55 No.S-1 October 2007
Clinical phase II study of garenoxacin in patients with respiratory tract infections -openlabel, multicenter, noncomparative-
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)Department of Respiratory Diseases, Kanagawa Prefectural Cardiovascular and Respiratory Diseases Center Hospital
(Present: Odagiri Respiratory Disease Clinic)
5)Department of Allergy and Respiratory Diseases, Douaikinen Hospital
(Present: Sano Toranomon Clinic)
6)First Department of Internal Medicine, School of Medicine, University of Ryukyus
(Present: Japanese Red Cross Nagasaki Genbaku Isahaya Hospital)
Abstract
The efficacy and safety of garenoxacin mesilate hydrate(GRNX), a des-F(6)-quinolone antibiotic, with 200 mg and 400 mg administered once daily were evaluated in patients with respiratory tract infections. Plasma concentrations of garenoxacin were determined preliminarily.
1. Clinical assessment: The efficacy rates were 96.0% (24/25) in 200 mg group and 87.5% (21/24) in 400 mg group at the end of treatment. The efficacy rates at the 7th day of post-treatment were 100% (19/19) in 200 mg group and 94.7% (18/19) in 400 mg group.
2. Bacteriological efficacy: The eradication rates were 100% (16/16) in 200 mg group and 70.0% (7/10) in 400 mg group at the end of treatment. The eradication rates at the 7th day of post-treatment were 100% (11/11) in 200 mg group and 6/8 in 400 mg group.
3. Safety: The incidence of drug-related adverse events was 9.7% (3/31) in 200 mg group and 6.5% (2/31) in 400 mg group. The incidence of drug-related laboratory abnormality was 26.7% (8/30) in 200 mg group and 19.4% (6/31) in 400 mg group.
4. Plasma concentration: The trough concentration of garenoxacin was 0.89±0.42 μg/mL in 200 mg group and 1.71±0.46 μg/mL in 400 mg group.
Results indicate that a 400 mg daily dose of GRNX gives a favorable prognosis in treatment for patients with respiratory tract infections.
Key word
garenoxacin, des-fluoro(6)-quinolone, respiratory infection, clinical study
Received
June 27, 2007
Accepted
July 26, 2007
Jpn. J. Chemother. 55 (S-1): 116-126, 2007
