title: Fidaxomicin for treatment of Clostridium difficile infection in clinical practice: a prospective cohort study in a French University Hospital.
abstract: OBJECTIVE
  Two randomized controlled trials (RCTs) showed the non-inferiority of fidaxomicin compared with vancomycin for Clostridium difficile infection (CDI) treatment and its superiority regarding recurrence rate. The aim of this study was to evaluate fidaxomicin's efficacy in clinical practice.
  
  
  METHODS
  This single-center prospective cohort study included hospitalized patients treated with fidaxomicin for CDI. Demographic, clinical and biological data were collected. Primary outcome was efficacy of fidaxomicin (clinical cure, recurrence and global cure) at 10 weeks. Secondary outcome was efficacy among different subgroups.
  
  
  RESULTS
  Ninety-nine patients were included: 42 severe CDI, 16 complicated CDI and 41 recurrent CDI. Rates of clinical cure, recurrence and global cure were 87, 15 and 59%, respectively. Subgroup analysis showed a higher recurrence rate for patients with recurrent CDI compared with first episode (8 vs. 26%; p = 0.04). Binary toxin was associated with severe/complicated CDI (80 vs. 50%; p < 0.01) and recurrence (32 vs. 7%; p < 0.01). Fidaxomicin was used as a first line for 83% of the patients with recurrence and for only 52% of first episodes even though 86% had recurrence's risk factors.
  
  
  CONCLUSIONS
  Compared with RCTs, fidaxomicin in real world is used for patients with more severe and recurrent CDI, but clinical cure and recurrence rates were similar. Comparative studies are needed in these specific subgroups. Our data also illustrate clinicians' difficulty to define a "patient at risk for recurrence" among the first episodes. Finally, we showed that binary toxin could be important in the screening for severity and recurrence risks.
authors.affiliation: Department of Infectious Diseases, Université Lille Nord de France, 59045, Lille, France. marie.pichenot@hotmail.fr.
authors.forename: Marie
authors.initials: M
authors.lastname: Pichenot
authors.affiliation: Department of Infectious Diseases, Université Lille Nord de France, 59045, Lille, France.
authors.forename: Rozenn
authors.initials: R
authors.lastname: Héquette-Ruz
authors.affiliation: Department of Infection Risk Management, Université Lille Nord de France, 59045, Lille, France.
authors.forename: Remi
authors.initials: R
authors.lastname: Le Guern
authors.affiliation: Department of Infection Risk Management, Université Lille Nord de France, 59045, Lille, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Grandbastien
authors.affiliation: Department of Infectious Diseases, Université Lille Nord de France, 59045, Lille, France.
authors.forename: Clément
authors.initials: C
authors.lastname: Charlet
authors.affiliation: Institute of Microbiology, Université Lille Nord de France, 59045, Lille, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Wallet
authors.affiliation: Department of Pharmacy, Université Lille Nord de France, 59045, Lille, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Schiettecatte
authors.affiliation: Department of Pharmacy, Université Lille Nord de France, 59045, Lille, France.
authors.forename: Fanny
authors.initials: F
authors.lastname: Loeuillet
authors.affiliation: Department of Infectious Diseases, Université Lille Nord de France, 59045, Lille, France.|Infectious Diseases Service, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.
authors.forename: Benoit
authors.initials: B
authors.lastname: Guery
authors.affiliation: Department of Infectious Diseases, Université Lille Nord de France, 59045, Lille, France.
authors.forename: Tatiana
authors.initials: T
authors.lastname: Galperine
mesh_terms: D000368:Aged; D000617:Aminoglycosides / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D016360:Clostridioides difficile / Q000187:drug effects; D003015:Clostridium Infections / Q000188:drug therapy*; D005260:Female; D000077732:Fidaxomicin; D005602:France; D006785:Hospitals, University; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000077732:Fidaxomicin
keywords: Clinical practice; Clostridium difficile; Fidaxomicin; Prospective