title: Randomized Controlled Noninferiority Trial Comparing Daptomycin to Vancomycin for the Treatment of Complicated Skin and Skin Structure Infections in an Observation Unit.
abstract: BACKGROUND
  Incidence of methicillin-resistant Staphylococcus aureus (MRSA) is increasing in complicated skin and skin structure infection (cSSSI) presenting to emergency departments (EDs). Treatment is heterogeneous and can require inpatient admission to an observation unit (OU). Vancomycin is commonly used in the OU for treatment, but increasing MRSA resistance to vancomycin suggests the need for alternatives. Daptomycin is an alternative but it is not known how it compares with vancomycin.
  
  
  OBJECTIVE
  This study tested the hypothesis that daptomycin is noninferior to vancomycin for the treatment of cSSSI in an OU, using a relative risk (RR) of 1.3 as the noninferiority limit.
  
  
  METHODS
  Subjects admitted to an ED-based OU with a diagnosis of cSSSI were eligible. Consenting subjects were randomized 1:1 to intravenous (i.v.) vancomycin at 15 mg/kg dosing every 12 h or i.v. daptomycin at 4 mg/kg once. Subjects were followed until they met objective criteria for discharge home or hospital admission. Discharged patients were prescribed 10-14 days of oral cephalexin and trimethoprim-sulfamethoxazole, or clindamycin if allergic to either of these medications. The primary endpoint was meeting objective discharge criteria with no change in antibiotic therapy or return to the ED for the same cellulitis within 30 days of OU discharge.
  
  
  RESULTS
  There were 100 patients enrolled. RR for satisfying the endpoint was 1.07 (95% confidence interval 0.58-1.98) for daptomycin compared with vancomycin. Hospital admission rates were 36% and 32% for daptomycin and vancomycin treatment, respectively.
  
  
  CONCLUSIONS
  Daptomycin was not inferior to vancomycin in the treatment of cSSSI in an OU.
authors.affiliation: Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio; Program in Biomedical Engineering, University of Cincinnati, Cincinnati, Ohio.
authors.forename: George J
authors.initials: GJ
authors.lastname: Shaw
authors.affiliation: Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Jason M
authors.initials: JM
authors.lastname: Meunier
authors.affiliation: Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Joseph
authors.initials: J
authors.lastname: Korfhagen
authors.affiliation: Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Beth
authors.initials: B
authors.lastname: Wayne
authors.affiliation: Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Hart
authors.affiliation: Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Lindsell
authors.affiliation: Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Gregory
authors.initials: G
authors.lastname: Fermann
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017576:Daptomycin / Q000008:administration & dosage / Q000627:therapeutic use*; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus; D011446:Prospective Studies; D013207:Staphylococcal Skin Infections / Q000188:drug therapy*; D016896:Treatment Outcome; D014640:Vancomycin / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D014640:Vancomycin; D017576:Daptomycin
keywords: ED observation unit; cellulitis; daptomycin; vancomycin