title: A randomized, double-blind, placebo-controlled pilot study to assess the ability of rifaximin to prevent recurrent diarrhoea in patients with Clostridium difficile infection.
abstract: BACKGROUND
  Uncontrolled case series have demonstrated decreased Clostridium difficile infection (CDI) recurrence in patients given rifaximin after standard antibiotic therapy. However, clinical trials assessing whether rifaximin decreases recurrent diarrhoea in patients with CDI have not been performed. The purpose of this study was to assess rates of recurrent diarrhoea in patients with CDI given rifaximin versus placebo immediately after standard therapy.
  
  
  METHODS
  This was a randomized, double-blind, placebo-controlled pilot study. Patients with CDI and a Horn's index ≥1 were randomized to receive rifaximin 400 mg three times daily or placebo for 20 days given immediately after finishing standard anti-CDI antibiotics. Patients were followed for 3 months and assessed for recurrent diarrhoea that included CDI recurrence (return of diarrhoea with a positive toxin test) and patient self-reported return of non-CDI diarrhoea after a period of wellness.
  
  
  RESULTS
  Sixty-eight patients aged 61 ± 18 years (50% male) were given rifaximin (n = 33) or placebo (n = 35). Twenty-four of 68 (35%) patients had recurrent diarrhoea either due to recurrent CDI (23.5%) or self-reported diarrhoea (11.5%). Recurrent diarrhoea occurred in 17 of 35 (49%) patients given placebo and 7 of 33 (21%) given rifaximin (P = 0.018). CDI recurrence occurred in 11 of 35 (31%) patients given placebo and 5 of 33 (15%) patients given rifaximin (P = 0.11). Self-reported diarrhoea occurred in 6 of 35 (17%) of patients given placebo and 2 of 33 (6%) given rifaximin (P = 0.15).
  
  
  CONCLUSIONS
  Patients with CDI given a rifaximin chaser regimen experienced a decreased incidence of recurrent diarrhoea compared with placebo.
authors.affiliation: University of Houston College of Pharmacy, Houston, TX 77030, USA. kgarey@uh.edu
authors.forename: Kevin W
authors.initials: KW
authors.lastname: Garey
authors.forename: Shashank S
authors.initials: SS
authors.lastname: Ghantoji
authors.forename: Dhara N
authors.initials: DN
authors.lastname: Shah
authors.forename: Musarat
authors.initials: M
authors.lastname: Habib
authors.forename: Vaneet
authors.initials: V
authors.lastname: Arora
authors.forename: Zhi-Dong
authors.initials: ZD
authors.lastname: Jiang
authors.forename: Herbert L
authors.initials: HL
authors.lastname: DuPont
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis / Q000379:methods*; D016360:Clostridioides difficile / Q000302:isolation & purification*; D003015:Clostridium Infections / Q000188:drug therapy* / Q000517:prevention & control*; D003967:Diarrhea / Q000188:drug therapy / Q000517:prevention & control; D004311:Double-Blind Method; D006801:Humans; D015994:Incidence; D010865:Pilot Projects; D010919:Placebos / Q000008:administration & dosage; D012294:Rifamycins / Q000008:administration & dosage*; D000078262:Rifaximin; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D010919:Placebos; D012294:Rifamycins; D000078262:Rifaximin