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Cloxacillin versus pristinamycin for superficial pyodermas: a randomized, open-label, non-inferiority study.

Author(s): Chosidow O, Bernard P, Berbis P, Humbert P, Crickx B, Jarlier V, ORPIC Study Investigator Group

Affiliation(s): Department of Internal Medicine, Hopital Pitie-Salpetriere, Assistance Publique-Hopitaux de Paris and Universite Paris-VI, France. olivier.chosidow@psl.ap-hop-paris.fr

Publication date & source: 2005, Dermatology., 210(4):370-4.

Publication type: Clinical Trial; Comparative Study ; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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

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