title: 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.
  
  
  OBJECTIVE
  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).
  
  
  CONCLUSIONS
  Cloxacillin could be an alternative to pristinamycin in out-patients with superficial pyodermas.
authors.affiliation: Department of Internal Medicine, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris and Université Paris-VI, France. olivier.chosidow@psl.ap-hop-paris.fr
authors.forename: O
authors.initials: O
authors.lastname: Chosidow
authors.forename: P
authors.initials: P
authors.lastname: Bernard
authors.forename: P
authors.initials: P
authors.lastname: Berbis
authors.forename: P
authors.initials: P
authors.lastname: Humbert
authors.forename: B
authors.initials: B
authors.lastname: Crickx
authors.forename: V
authors.initials: V
authors.lastname: Jarlier
mesh_terms: D000284:Administration, Oral; D003023:Cloxacillin / Q000008:administration & dosage*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D008297:Male; D025762:Pristinamycin / Q000008:administration & dosage*; D011711:Pyoderma / Q000175:diagnosis* / Q000188:drug therapy*; D012016:Reference Values; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D025762:Pristinamycin; D003023:Cloxacillin