title: Oral pristinamycin versus standard penicillin regimen to treat erysipelas in adults: randomised, non-inferiority, open trial.
abstract: OBJECTIVE
  To assess the efficacy and safety of oral pristinamycin versus intravenous then oral penicillin to treat erysipelas in patients in hospital.
  
  
  METHODS
  Multicentre, parallel group, open labelled, randomised non-inferiority trial.
  
  
  METHODS
  22 French hospitals.
  
  
  METHODS
  289 adults admitted to hospital with erysipelas.
  
  
  RESULTS
  At follow up (day 25-45) the cure rate (primary efficacy end point) for the per protocol populations was 81% (83/102) for pristinamycin and 67% (68/102) for penicillin. The planned interim analysis (global one sided type I error 5%) showed that the one sided 97.06% confidence interval of the observed difference (pristinamycin-penicillin) between cure rates (3.3% to infinity ) exceeded the -10% non-inferiority threshold. For the intention to treat populations the cure rate at follow up was 65% (90/138) for pristinamycin and 53% (79/150) for penicillin, with the one sided 97.06% confidence interval of the observed difference between cure rates (1.7% to infinity ) exceeding the -10% non-inferiority threshold. That the lower limit of the confidence interval exceeded the -10% threshold and was also >0 supports the hypothesis that pristinamycin is significantly superior at the 5% level. More adverse events related to treatment, as assessed by the investigators, were reported in the pristinamycin group than in the penicillin group. Most adverse events involved the gastrointestinal tract (nausea, vomiting, and diarrhoea) but were minor and usually did not require discontinuation of treatment.
  
  
  CONCLUSIONS
  Pristinamycin could be an alternative to the standard intravenous then oral penicillin regimen used to treat erysipelas in adults in hospital, with the advantages of oral first line therapy.
authors.affiliation: Department of Dermatology, Hôpital Robert-Debré, 51092 Reims, France. pbernard@chu-reims.fr
authors.forename: Philippe
authors.initials: P
authors.lastname: Bernard
authors.forename: Olivier
authors.initials: O
authors.lastname: Chosidow
authors.forename: Loïc
authors.initials: L
authors.lastname: Vaillant
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D016022:Case-Control Studies; D004886:Erysipelas / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010406:Penicillins / Q000008:administration & dosage*; D025762:Pristinamycin / Q000008:administration & dosage*; D011446:Prospective Studies; D012307:Risk Factors
chemical_list: D000900:Anti-Bacterial Agents; D010406:Penicillins; D025762:Pristinamycin