Vol.53 No.S-3 December 2005
Phase III clinical study of BAY 12-8039 (moxifloxacin) for respiratory tract infections
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 efficacy and safety of BAY 12-8039 (moxifloxacin: MFLX), a novel new quinolone compound, were evaluated in patient with respiratory tract infections. Patients were treated for 7 days with MFLX 400 mg once daily.
The clinical efficacy rate was 98.3% (57/58 cases) for acute upper respiratory tract infections (Group I), 100% (26/26) for atypical pneumonia (Group II-1) and 87.7% (57/65) for secondary infections (or acute exacerbation) in patient with chronic respiratory tract diseases (Group II-2). The eradication rate was 100% (24/24) for Group I and 86.1% (31/36) for Group II-2. The overall eradication rate was 91.7% (55/60). Good eradication rates were obtained in every diagnostic group.
The incidence of adverse drug reactions were noted in 32.5% (65 cases) of all patients. Adverse drug reactions were most commonly observed in digestive organs in 20.0% (40 cases). The most common adverse drug reactions were abnormal liver function tests and diarrhea, and their incidence rate was 8.5% (17 cases) and 5.5% (11 cases), respectively.
The above results suggested that 400 mg of MFLX administered once daily should be clinically very useful in the treatment of respiratory tract infections.
Key word
moxifloxacin, respiratory tract infection, clinical trial
Received
October 3, 2005
Accepted
November 24, 2005
Jpn. J. Chemother. 53 (S-3): 47-59, 2005
