Efficacy of cefaclor AF in the treatment of skin and skin-structure infections.

Cefaclor advanced formulation (cefaclor AF) was compared with cefaclor for the treatment of skin and skin-structure infections in a double-blind study at 28 centers in North America. Of the 563 patients originally randomized, 278 patients received cefaclor AF (375 mg twice daily) and 285 patients received cefaclor (250 mg three times daily). A total of 154 patients treated with cefaclor AF and 157 patients treated with cefaclor qualified for the efficacy analysis after completing 7 days of therapy. At the post-therapy visit, favorable clinical response rates for evaluable patients were 97.4% in the cefaclor AF group and 94.9% in the cefaclor group; favorable bacteriologic response rates were 85.7% and 84.1%, respectively. At the late post-therapy evaluation, 7 to 14 days after completion of therapy, favorable clinical response rates were 90.1% in the cefaclor AF group versus 89.9% in the cefaclor group, and favorable bacteriologic response rates were 88.7% and 86.9%, respectively. No significant difference was seen between the groups in clinical or bacteriologic efficacy at either evaluation or in the frequency of nature of side effects reported during the study.