title: An antimicrobial stewardship program's real-world experience with fidaxomicin for treatment of Clostridium difficile infection: a case series.
abstract: OBJECTIVE
  To evaluate real-world clinical and economic outcomes in patients with Clostridium difficile infection (CDI) treated with fidaxomicin.
  
  
  METHODS
  Retrospective case series.
  
  
  METHODS
  Academic medical center.
  
  
  METHODS
  A total of 61 patients with CDI who were treated with fidaxomicin monotherapy or combination therapy from September 2011 to December 2012.
  
  
  RESULTS
  Data on demographics, infection characteristics, and clinical and economic outcomes were evaluated. Clinical cure was defined as resolution of diarrhea (less than or equal to three unformed stools for at least 2 consecutive days) maintained for the duration of therapy with no further requirement for CDI therapy and was achieved in 44 (72.1%) patients. Clinical cure was significantly higher for patients receiving fidaxomicin monotherapy compared with fidaxomicin combination therapy (25/29 [86.2%] patients vs 19/32 [59.4%] patients, p=0.04). Clinical cure was similar in patients with a first or prior CDI episode (65.5% vs 78.1%, p=0.27) and in patients with severe versus nonsevere disease (68.4% vs 73.8%, p=0.66). Recurrence occurred in 6 (13.6%) of the 44 patients who achieved clinical cure. Mortality attributable to CDI was 11.5%, and 30-day readmission rate was 4.9%. Median cost accrued during CDI was $19,483/patient.
  
  
  CONCLUSIONS
  Our real-world experience with fidaxomicin significantly differs from the findings of phase III clinical trials. Fidaxomicin is also associated with substantial costs. Multicenter studies are needed to determine the optimal role of fidaxomicin in the treatment of CDI.
authors.affiliation: Department of Pharmacy, The Ohio State University, Wexner Medical Center, Columbus, Ohio.
authors.forename: Craig A
authors.initials: CA
authors.lastname: Vargo
authors.forename: Karri A
authors.initials: KA
authors.lastname: Bauer
authors.forename: Julie E
authors.initials: JE
authors.lastname: Mangino
authors.forename: Jessica E W
authors.initials: JE
authors.lastname: Johnston
authors.forename: Debra A
authors.initials: DA
authors.lastname: Goff
mesh_terms: D000046:Academic Medical Centers; D000368:Aged; D000617:Aminoglycosides / Q000008:administration & dosage / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D016360:Clostridioides difficile / Q000302:isolation & purification*; D003015:Clostridium Infections / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality; D004359:Drug Therapy, Combination; D005260:Female; D000077732:Fidaxomicin; D006801:Humans; D008297:Male; D008875:Middle Aged; D010359:Patient Readmission / Q000706:statistics & numerical data; D012008:Recurrence; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000617:Aminoglycosides; D000890:Anti-Infective Agents; D000077732:Fidaxomicin
keywords: Antimicrobial stewardship; CDI; Clostridium difficile infection; fidaxomicin