Cefdinir versus XXXX for the treatment of skin and skin-structure infections. The Cefdinir Adult Skin Infection Study Group.

@entity1 @entity294 @entity7265 @entity5353
Because of increasing resistance to older antimicrobial agents, newer drugs need to be evaluated for the treatment of skin and skin-structure infections (SSSIs). This double-masked, randomized, comparative, multicenter study enrolled @entity1 aged 13 years or older with SSSIs to receive either cefdinir 300 mg @entity5353 or @entity7265 500 mg QID for 10 days. Nine hundred fifty-two @entity1 (474 in the cefdinir group and 478 in the @entity7265 group) took part, primarily white males between 18 and 65 years of age. There were two follow-up visits, with efficacy determined at the test-of-cure visit, 7 to 16 days posttherapy. Many @entity1 were not microbiologically assessable, primarily because of negative cultures at study admission. @entity1 who required surgical intervention (e.g., incision and drainage) at the site of infection more than 24 hours after the initiation of drug therapy were defined as treatment failures. Significantly more isolated pathogens were resistant to @entity7265 than to cefdinir. In the 178 efficacy-assessable cefdinir-treated @entity1 , the rate of pathogen eradication was 93% (200/215), and the rate of successful clinical response was 88% (157/178), compared with 89% (221/247) and 87% (177/204), respectively, in the 204 efficacy-assessable @entity7265 -treated @entity1 . Using confidence-interval analysis, the microbiologic and clinical response rates of the cefdinir-treated @entity1 were statistically equivalent to those of the @entity7265 -treated @entity1 . At the follow-up visits, @entity1 were questioned about any adverse events occurring since their previous visit. Any untoward symptom occurring during or within 2 days after completion of drug treatment was considered an adverse reaction if the investigator judged it to be definitely, probably, or possibly related to the study drug. One hundred twenty-three (26%) cefdinir-treated @entity1 and 77 (16%) @entity7265 -treated @entity1 experienced at least one adverse reaction, a statistically significant difference. Study drug was discontinued for adverse reactions in 20 (4%) cefdinir-treated @entity1 and 13 (3%) @entity7265 -treated @entity1 ; in the two groups, 10 and 7 @entity1 , respectively, were discontinued for @entity294 . Cefdinir taken @entity5353 was as effective as @entity7265 taken QID in the treatment of mild-to-moderate SSSIs and was well tolerated by most @entity1 . The increased antibacterial activity of cefdinir must be balanced against the higher rate of @entity294 seen in @entity1 treated with this drug.
