Vol.53 No.S-3 December 2005
Phase III double-blind comparative study of BAY 12-8039 (moxifloxacin) versus levofloxacin in patients with community-acquired pneumonia
1)Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo, Japan
2)Department of Internal Medicine, Shinrakuen Hospital
3)Division of Respiratory Diseases, Department of Internal Medicine, Kawasaki Medical School
4)Department of Respiratory Medicine, Division of Cancer Control, Institute of Development, Aging and Cancer, Tohoku University
5)Department of Infectious Disease , Kyorin University School of Medicine
6)Department of Rspiratory Diseases, Kanagawa Prefectural Cardiovascular and Respiratory Diseases Center Hospital (Present: Odagiri Respiratory Disease Clinic, Yokohama Clinical Research Institute of Respiratory Tract Infection Yokohama City University School of Medicine)
7)Division of Molecular and Clinical Microbiology, Department of Microbiology and Immunology, Nagasaki University Graduate School of Medical Sciences
8)Department of Microbiology, Toho University School of Medicine
9)Department of Medicine and Therapeutics, Control and Prevention of Infectious Diseases, Faculty Medicine, University of Ryukyus (Present: The Japanese Red Cross Nagasaki Genbaku Isahaya Hospital)
Abstract
The clinical efficacy and safety of moxifloxacin (MFLX), a novel new quinolone compound, and levofloxacin (LVFX) were compared in the treatment patients with community-acquired pneumonia in a double-blind, randomized, group comparative study. Patients were treated for 10 days with either MFLX 400 mg orally once daily (MFLX group) or LVFX 100 mg three times daily (LVFX group).
Overall clinical reponse in 246 patients evaluable for efficacy were 94.0% (110/117 patients) in the MFLX group and 94.6% (122/129) in the LVFX group. It was demonstrated that MFLX is not inferior to LVFX. Overall bacteriological response in 86 patients evaluable for bacteriological efficacy was 92.3% (36/39 patients) in the MFLX group and 82.6% (38/46) in the LVFX group. Eradication rate by causative organisms in overall bacteriological response was 92.7% (38/41) in the MFLX group and 84.3% (43/51) in the LVFX group. The incidence rate of adverse drug reaction was 16.8% (25/149 patients) in the MFLX group and 11.1% (17/153) in the LVFX group.
The above results suggested that a 400 mg oral dose of MFLX once daily for 10 days should be very useful clinically in the treatment of community-acquired pneumonia.
Key word
community-acquired pneumonia, double-blind trial, moxifloxacin, levofloxacin
Received
October 3, 2005
Accepted
November 24, 2005
Jpn. J. Chemother. 53 (S-3): 27-46, 2005
