Cloxacillin versus Pristinamycin for Superficial Pyodermas: A Randomized, Open-Label, Non-Inferiority Study

Abstract

Background: Superficial pyodermas may require systemic antibiotics. In a previous open-label trial, oxacillin and pristinamycin achieved similar cure rates, but its design was not truly that of a non-inferiority study. Objectives: To assess the efficacy and safety of oral cloxacillin versus pristinamycin (both 2 g/day) to treat superficial pyodermas. Methods: Multicentre, parallel-group, open-label, randomized non-inferiority trial. Results: French general practitioners in private practice included 334 out-patients (mean age: 42 years). At the follow-up (day 14), the cure rates (primary efficacy end point) for the intent-to-treat populations were 80.7% (138/171) for cloxacillin and 82.8% (135/163) for pristinamycin. The observed difference between cure rates was –2.1%, with the lower limit of the two-sided 95% confidence interval higher than the non-inferiority threshold of –15%. The per-protocol analysis yielded similar results. Therapy was discontinued for 10 patients (cloxacillin: 1, pristinamycin: 9; p = 0.01). Conclusion: Cloxacillin could be an alternative to pristinamycin in out-patients with superficial pyodermas.