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Systemic antimicrobial therapy for skin and skin structure infections: comparison of fleroxacin and ceftazidime.

Intravenous fleroxacin, 400 mg once a day, was compared with ceftazidime, 0.5-2 g three times a day or 1-2 g twice a day, for the treatment of skin and skin structure infections. Duration of treatment was 4-21 days. The study was a multicenter, unblinded comparison. Of the 316 patients enrolled, 212 were randomized to treatment with fleroxacin and 104 to ceftazidime (2:1 ratio); 92 fleroxacin-treated patients and 50 ceftazidime-treated patients were included in the standard analysis of efficacy. The most common diagnoses were wound infections and cellulitis, which affected 36% and 30% of the fleroxacin group, and 24% and 24% of the ceftazidime group, respectively. In the fleroxacin group, 82% of the infecting organisms were eradicated, and in the ceftazidime group, 79%. The overall rates of bacteriologic cure, by infection, were 79% for the fleroxacin group and 74% for the ceftazidime group, and those for clinical cure were 82% and 73%, respectively. It could not be concluded with 95% confidence that the two regimens resulted in equivalent cure rates because the range of between-group differences was outside the stipulated limits of +/- 15%. The percentage of patients with one or more adverse events was approximately twice as high (17% vs. 9%) in the fleroxacin group than in the ceftazidime group. The most frequent event in both groups was nausea. In this study, intravenous therapy with fleroxacin or ceftazidime produced similar bacteriologic and clinical cure rates, but the statistical requirements permitting a conclusion of equivalence at protocol levels were not met.