Pharmacology and Treatment
Cloxacillin versus Pristinamycin for Superficial Pyodermas: A Randomized, Open-Label, Non-Inferiority StudyChosidow O.a · Bernard P.d · Berbis P.e · Humbert P.f · Crickx B.b · Jarlier V.b
aDepartment of Internal Medicine, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris and Université Paris-VI, bDepartment of Dermatology, Hôpital Bichat, and cDepartment of Bacteriology, Hôpital Pitié-Salpêtrière, Paris, dDepartment of Dermatology, Hôpital Robert-Debré, Reims, eDepartment of Dermatology, Hôpital Nord, Marseille, and fDepartment of Dermatology, Hôpital Saint-Jacques, Besançon, France
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Article / Publication Details
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.
© 2005 S. Karger AG, Basel
Article / Publication Details
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