BAY 12-8039 (moxifloxacin) Phase III study of the treatment of skin and skin structure infections

The clinical efficacy and safety of BAY 12-8039 (moxifloxacin: MFLX), a novel new quinolone compound, were evaluated in patients with skin and structure infections. The dosage of MFLX was 400 mg once daily for 7 days. The overall clinical efficacy was 78.6% (22/28) in group I-a, 93.8% (15/16) in group I-b, 73.2% (41/56) in group II-a, 100% (12/12) in group II-b and 45.5% (15/33) in group III. The bacteriological eradication rate was 78.3% (18/23) in group I-a, 75.0% (12/16) in group I-b, 75.5% (37/ 49) in group II-a, 100% (4/4) in group II-b and 69.0% (20/29) in group III. The patients for group III did not improve sufficiently even though causative organisms were eliminated. It may be because infections in group III were based on local underlying conditions. Therefore, antibacterial drugs alone are insufficient to improve these infections. For group III, further assessment is required. The incidence of adverse drug reactions was 25.6% (40/156). The most common adverse drug reactions were digestive disorders, such as nausea, diarrhea, and stomach discomfort. All of symptoms were mild to moderate. The results suggest that MFLX tablet will be clinically useful for the treatment of skin and skin structure infections.