Efficacy and safety of garenoxacin in the treatment of upper respiratory tract infections

Objective: To determine the efficacy and safety of garenoxacin, a new generation of quinolone antimicrobial agent, in the treatment of adult upper respiratory tract infections. Methods: A total of 113 subjects were enrolled in this study. Garenoxacin (400 mg/day) was administered to patients with pharyngolaryngitis, tonsillitis, and otitis media for 5-7 days and to those with sinusitis for 7-10 days. Clinical symptoms and findings were examined and quantitatively evaluated using a scoring system. Results: We found 80 to 100% improvement rate in symptoms and findings for each infection. In addition, we found significant improvement in subjective evaluations from patient questionnaires even in the early stage of the treatment. X-ray examination for acute sinusitis demonstrated that the clinical efficacy was 84% (27/32) and 76%(19/25) patients were already improved within seven days. Among the detected 84 bacteria, 75 (89%) were identified as the major pathogenic bacteria of respiratory tract infections such as Streptococcus pneumoiae (27 strains) and Haemophillus influenzae (14 strains). Garenoxacin administration completely eradicated bacteria in 53 out of 54 cases (98%). There were 8 adverse events (8.3%) including 3 diarrhea cases (3.1%). Conclusion: These results suggest that garenoxacin is a highly effective and safe antimicrobial agent in the treatment of community-acquired upper respiratory infections. Additionally, garenoxacin did not induce the growth of resistant bacteria because of its strong antimicrobial activity. (C) 2011 Elsevier Ireland Ltd. All rights reserved.