Double-blind comparative study of sitafloxacin versus levofloxacin in patients with respiratory tract infection

The clinical efficacy and safety of sitafloxacin(STFX), a fluoroquinolone compound, and levofloxacin (LVFX) were objectively compared in the treatment of patients with pneumonia, secondary infection, or acute exacerbation of chronic respiratory tract disease in a double-blind, randomized, group-comparative study. Patients were treated for 7 days with either STFX 50 mg orally twice daily (STFX group) or LVFX 100 mg three times daily (LVFX group). The clinical efficacy rate at the end of treatment in 208 evaluable patients was 92.5% (99/107) in the STFX group and 92.1% (93/101) in the LVFX group. STFX was found to be not inferior to LVFX. The clinical efficacy rate was 96.4% (53/55) in the STFX group and 94.0% (47/50) in the LVFX group for pneumonia and 88.5% (46/52) in the STFX group and 90.2% (46/51) in the LVFX group for secondary infection or acute exacerbation of chronic respiratory tract disease. Eradication in 97 patients evaluable for bacteriological response was 78A% (40/51) in the STFX group and 80.4% (37/46) in the LVFX group. Based on bacterium disappearance by causative bacterium, 95.0% (19/20) of Gram-positive bacteria was eradicated in the STFX group and 87.5% (21/24) in the LVFX group. For Gram-negative bacteria, 79.4% (27/34) was eradicated in the STFX group and 81.5% (22/27) in the LVFX group. The incidence of adverse drug reaction was 29.8% (34/114) in the STFX group and 25.9% (30/116) in the LVFX group. These results suggest that a 50 mg oral dose of STFX twice daily for 7 days is clinically useful in the treatment of respiratory tract infection.