CEFDINIR VERSUS CEPHALEXIN FOR THE TREATMENT OF SKIN AND SKIN-STRUCTURE INFECTIONS

Because of increasing resistance to older antimicrobial agents, newer drugs need to be evaluated for the treatment of skin and skin-structur e infections (SSSIs). This double-masked, randomized, comparative, mul ticenter study enrolled patients aged 13 years or older with SSSIs to receive either cefdinir 300 mg BID or cephalexin 500 mg QID for 10 day s. Nine hundred fifty-two patients (474 in the cef dinir group and 478 in the cephalexin group) took part, primarily white males between 18 and 65 years of age. There were two follow-up visits, with efficacy de termined at the test-of-cure visit, 7 to 16 days posttherapy. Many pat ients were not microbiologically assessable, primarily because of nega tive cultures at study admission. Patients who required surgical inter vention leg, incision and drainage) at the site of infection more than 24 hours after the initiation of drug therapy were defined as treatme nt failures. Significantly more isolated pathogens were resistant to c ephalexin than to cefdinir. In the 178 efficacy-assessable cefdinir-tr eated patients, the rate of pathogen eradication was 93% (200/215), an d the rate of successful clinical response was 88% (157/178), compared with 89% (221/247) and 87% (177/204), respectively, in the 204 effica cy-assessable cephalexin-treated patients. Using confidence-interval a nalysis, the microbiologic and clinical response rates of the cefdinir -treated patients were statistically equivalent to those of the cephal exin-treated patients. At the follow-up visits, patients were question ed 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 stud y drug. One hundred twenty-three (26%) cefdinir-treated patients and 7 7 (16%) cephalexin-treated patients experienced at least one adverse r eaction, a statistically significant difference. Study drug was discon tinued for adverse reactions in 20 (4%) cefdinir-treated patients and 13 (3%) cephalexin-treated patients; in the two groups, 10 and 7 patie nts, respectively, were discontinued for diarrhea. Cefdinir taken BID was as effective as cephalexin taken QID in the treatment of mild-to-m oderate SSSIs and was well tolerated by most patients. The increased a ntibacterial activity of cefdinir must be balanced against the higher rate of diarrhea seen in patients treated with this drug.