We performed a double blind, multicenter, clinical trial to compare BMY-28100 (a new oral cephem antibiotic) and cefaclor (CCL) in terms of efficacy, safety and clinical usefulness. Both drugs were ...given orally in a dose of 250mg three times a day after meals. The duration of therapy was 7 days for the disease groups I-IV and VI and 10 days for the disease group V. In all, 252 patients were enrolled, 126 for each drug group. Of these, 227 (BMY-28100, 116; CCL, 111) were analyzed for efficacy, 245 (BMY-28100, 121; CCL, 124) for Safety and 277 (BMY-28100, 116; CCL, 111) for usefulness. 1. Overall clinical efficacy rates were 81.9%(95/116) in the BMY-28100 group and 82.9%(92/111) in the CCL group, the difference being not statistically significant. In group I, the rate of “excellent” response was significantly higher in the BMY-28100 group than in the CCL group. 2. The bacteriological response, (eradication) rates were 86.3%(63/73) in the BMY-28100 group and 79.3 (46/58) in the CCL group, the difference being not statistically significant. However, Staphylococcus aureus was eradicated in 95.8%(23/29) in the BMY-28100 group and in 66.7%(8/12) in the CCL group. This difference was statistically significant. 3. Adverse effects were minor in both drug groups. The incidences (3.3% in the BMY-28100 group and 2.4% in the CCL group) were low and not significantly different from each other. Abnormal laboratory findings were seen in 2.9%(3/105) of the BMY-28100 group and in 8.6%(9/105) of the CCL group, the difference being not statistically significant. Overall safety was evaluated by considering adverse effects and abnormal laboratory findings. Overall safety rates were 90.1%(109/121) in the BMY-28100 group and 89.5 (111/124) in the CCL group with no significant difference between the groups. 4. Usefulness was evaluated by considering efficacy and safety. Usefulness rates were 81.9%(95/116) for the BMY-28100 group and 80.2%(89/111) for the CCL group with no significant difference between the groups. We consider BMY-28100 to be as effective, safe and useful as CCL for skin and skin structure infections.
