title: Double-blind, double-dummy comparison of azithromycin and cephalexin in the treatment of skin and skin structure infections.
abstract: In this double-blind, randomised trial conducted in 22 centres in the USA, azithromycin given over five days, as a once-a-day regimen, (500 mg on day 1, 250 mg on days 2-5) was compared with cephalexin (500 mg b.i.d.) given for ten days in the treatment of patients with skin and skin structure infections. A total of 366 patients entered the study and 179 of these were eligible for the efficacy analysis. The overall clinical response to azithromycin was 94.0%, compared with 95.8% for cephalexin. The clinical cure rates were 53.0% for azithromycin and 59.4% for cephalexin; the respective improvement rates were 41.0% and 36.5%. Distribution of response (cured, improved, failed) was similar in each group (p = 0.37). The bacteriological eradication rate for azithromycin-treated patients was 94.2% and for cephalexin-treated patients was 90.3% (p = 0.34). Clinical and bacteriological response was similar in each group for all primary diagnoses. The two antibiotics were well tolerated, the overall incidence of side effects being 13.7% with approximately 60% due to gastrointestinal disturbances. In all but one case (cephalexin) the severity of the reported side effects was mild or moderate. Six patients withdrew from the study due to treatment-related events; five had been treated with azithromycin and one with cephalexin. In summary, a five-day, once-daily regimen of azithromycin was as effective as a ten-day, twice-daily regimen of cephalexin in the treatment of patients with skin and skin structure infections.
authors.affiliation: Department of Medicine, University of Illinois, Chicago 60612.
authors.forename: R
authors.initials: R
authors.lastname: Kiani
mesh_terms: D000038:Abscess / Q000188:drug therapy; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017963:Azithromycin; D002481:Cellulitis / Q000188:drug therapy; D002506:Cephalexin / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004917:Erythromycin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007169:Impetigo / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D012874:Skin Diseases, Infectious / Q000188:drug therapy*; D014946:Wound Infection / Q000188:drug therapy
chemical_list: D004917:Erythromycin; D017963:Azithromycin; D002506:Cephalexin