Phase III clinical study of BAY 12-8039 (moxifloxacin) for respiratory tract infections

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.