title: An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection.
abstract: BACKGROUND
  Treatment of complicated skin and skin structure infection (cSSSI) places a tremendous burden on the health care system. Understanding relative resource utilization associated with different antimicrobials is important for decision making by patients, health care providers, and payers.
  
  
  METHODS
  The authors conducted an open-label, pragmatic, randomized (1:1) clinical study (N = 250) to compare the effectiveness of daptomycin with that of vancomycin for treatment of patients hospitalized with cSSSI caused by suspected or documented methicillin-resistant Staphylococcus aureus infection. The primary study end point was infection-related length of stay (IRLOS). Secondary end points included health care resource utilization, cost, clinical response, and patient-reported outcomes. Patient assessments were performed daily until the end of antibiotic therapy or until hospital discharge, and at 14 days and 30 days after discharge.
  
  
  RESULTS
  No difference was found for IRLOS, total LOS, and total inpatient cost between cohorts. Hospital LOS contributed 85.9% to the total hospitalization cost, compared with 6.4% for drug costs. Daptomycin showed a nonsignificant trend toward a higher clinical success rate, compared with vancomycin, at treatment days 2 and 3. In the multivariate analyses, vancomycin was associated with a lower likelihood of day 2 clinical success (odds ratio [OR] = 0.498, 95% confidence interval [CI], 0.249-0.997; P < 0.05).
  
  
  CONCLUSIONS
  This study did not provide conclusive evidence of the superiority of one treatment over the other in terms of clinical, economic, or patient outcomes. The data suggest that physician and patient preference, rather than drug acquisition cost, should be the primary driver of initial antibiotic selection for hospitalized patients with cSSSI.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01419184 (Date: August 16, 2011).
authors.affiliation: Health Economics and Outcomes Research, Merck & Co., Inc., 2000 Galloping Road, Kenilworth, NJ, 07033, USA. tkandrb@gmail.com.
authors.forename: Teresa L
authors.initials: TL
authors.lastname: Kauf
authors.affiliation: Global Center for Scientific Affairs, Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA. peggy.mckinnon@merck.com.
authors.forename: Peggy
authors.initials: P
authors.lastname: McKinnon
authors.affiliation: Department of Medicine, Duke University Health System, Durham, NC, USA. g.corey@duke.edu.
authors.forename: G Ralph
authors.initials: GR
authors.lastname: Corey
authors.affiliation: University of Texas at Austin Dell Medical School, Austin, TX, USA. jbedolla@seton.org.
authors.forename: John
authors.initials: J
authors.lastname: Bedolla
authors.affiliation: Albert Einstein College of Medicine Montefiore Medical Center, Bronx, NY, USA. priska@montefiore.org.
authors.forename: Paul F
authors.initials: PF
authors.lastname: Riska
authors.affiliation: Infectious Diseases Research, William Beaumont Hospital, Royal Oak, MI, USA. matthew.sims@beaumont.edu.
authors.forename: Matthew
authors.initials: M
authors.lastname: Sims
authors.affiliation: Medical Research, Mercy Saint Vincent Medical Center, Toledo, OH, USA. luis_jauregui@mhsnr.org.
authors.forename: Luis
authors.initials: L
authors.lastname: Jauregui-Peredo
authors.affiliation: JM Still Burn Center at Doctors Hospital, Augusta, GA, USA. brucefriedman.md@gmail.com.
authors.forename: Bruce
authors.initials: B
authors.lastname: Friedman
authors.affiliation: Northeast Iowa Medical Education Foundation, Waterloo, IA, USA. jhoehns@neimef.org.
authors.forename: James D
authors.initials: JD
authors.lastname: Hoehns
authors.affiliation: Pharmacy and Medicine, University of New Mexico, Albuquerque, NM, USA. rmercier@salud.unm.edu.
authors.forename: Renée-Claude
authors.initials: RC
authors.lastname: Mercier
authors.affiliation: Department of Infectious Diseases, Ochsner Clinic Foundation, New Orleans, LA, USA. jgarcia-diaz@ochsner.org.
authors.forename: Julia
authors.initials: J
authors.lastname: Garcia-Diaz
authors.affiliation: Health Economics and Outcomes Research, Optum, Eden Prairie, MN, USA. susan.brenneman@optum.com.
authors.forename: Susan K
authors.initials: SK
authors.lastname: Brenneman
authors.affiliation: Department of Emergency Medicine, Nassau University Medical Center, East Meadow, NY, USA. dng@numc.edu.
authors.forename: David
authors.initials: D
authors.lastname: Ng
authors.affiliation: Albany College of Pharmacy and Health Sciences, Albany, NY, USA. thomas.lodise@acphs.edu.
authors.forename: Thomas
authors.initials: T
authors.lastname: Lodise
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D017576:Daptomycin / Q000191:economics / Q000627:therapeutic use*; D016527:Drug Costs; D005260:Female; D017721:Hospital Costs; D006801:Humans; D007902:Length of Stay / Q000191:economics; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus / Q000472:pathogenicity; D008875:Middle Aged; D012874:Skin Diseases, Infectious / Q000188:drug therapy* / Q000382:microbiology; D013203:Staphylococcal Infections / Q000188:drug therapy; D016896:Treatment Outcome; D014640:Vancomycin / Q000191:economics / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D014640:Vancomycin; D017576:Daptomycin