Vol.56 No.S-1 April 2008
Phase III double-blind comparative study of sitafloxacin versus tosufloxacin in patients with community-acquired pneumonia
1)Japanese Red Cross Nagasaki Genbaku Isahaya Hospital, 986-2 Keya, Tarami-machi, Isahaya, Nagasaki, Japan
2)Research Division for Department of Anti-Infective Agents, Institute of Development, Aging and Cancer, Tohoku University
3)Department of Internal Medicine, Shinrakuen Hospital
4)Department of Clinical Infectious Diseases, School of Medicine, Showa University
5)Division of Molecular and Clinical Microbiology, Department of Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences
6)Field of Infection Control and Laboratory Diagnostics, Internal Medicine, Tohoku University Graduate School of Medicine
7)Department of Pharmacology, Jikei University School of Medicine
Abstract
Sitafloxacin(STFX), a fluoroquinolone antimicrobial agent, has potent antimicrobial activity against Streptococcus pneumoniae, the major pathogenic bacteria in respiratory tract infections. The clinical efficacy and safety of STFX and tosufloxacin(TFLX) were compared in the treatment patients with community-acquired pneumonia in a double-blind, randomized, group-comparative study. Patients were treated orally twice daily 7 days with either STFX at 100 mg (STFX group) or TFLX at 150 mg three times daily (TFLX group).
Clinical efficacy in 225 patients was 93.3% (111/119 patients) in the STFX group and 89.6% (95/106 patients) in the TFLX group. STFX was found to be not inferior to TFLX. Bacteriological response in 93 patients was 100% (42/42 patients) in the STFX group and 88.2% (45/51 patients) in the TFLX group. Eradication of causative organisms in overall bacteriological response was 100% (48/48) in the STFX group and 91.1% (51/56) in the TFLX group. Eradication rate of S. pneumoniae was 100% (14/14) in the STFX group and 87.0% (20/23) in the TFLX group. The incidence of adverse drug reactions (ARs) was 48.4% (61/126 patients) in the STFX group and 40.5% (49/121 patients) in the TFLX group. No severe ARs were observed in either groups, indicating that STFX is well tolerated in the treatment of community-acquired pneumonia.
Results suggest that a 50 mg oral dose of STFX twice daily for 7 days is useful clinically in the treatment of community-acquired pneumonia.
Key word
community acquired pneumonia, double blind study, sitafloxacin, tosufloxacin, fluoroquinolone
Received
October 22, 2007
Accepted
December 6, 2007
Jpn. J. Chemother. 56 (S-1): 49-62, 2008
