A randomized, double-blind, placebo-controlled pilot study to assess the ability of rifaximin to prevent recurrent diarrhoea in patients with Clostridium difficile infection
Open Access
- 21 September 2011
- journal article
- research article
- Published by Oxford University Press (OUP) in Journal of Antimicrobial Chemotherapy
- Vol. 66 (12), 2850-2855
- https://doi.org/10.1093/jac/dkr377
Abstract
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. 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. 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). Patients with CDI given a rifaximin chaser regimen experienced a decreased incidence of recurrent diarrhoea compared with placebo.This publication has 21 references indexed in Scilit:
- Increased rate of irritable bowel syndrome and functional gastrointestinal disorders after Clostridium difficile infectionJournal of Hospital Infection, 2011
- Rifaximin Therapy for Patients with Irritable Bowel Syndrome without ConstipationNew England Journal of Medicine, 2011
- Clostridium difficileinfection: update on emerging antibiotic treatment options and antibiotic resistanceExpert Review of Anti-infective Therapy, 2010
- In vitro susceptibility ofClostridium difficileto rifaximin and rifampin in 359 consecutive isolates at a university hospital in Houston, TexasJournal of Clinical Pathology, 2010
- Treatment with Monoclonal Antibodies againstClostridium difficileToxinsNew England Journal of Medicine, 2010
- Pretreatment of Epithelial Cells with Rifaximin Alters Bacterial Attachment and Internalization ProfilesAntimicrobial Agents and Chemotherapy, 2010
- High Frequency of Rifampin Resistance Identified in an EpidemicClostridium difficileClone from a Large Teaching HospitalClinical Infectious Diseases, 2009
- Rifaximin in Treatment of Recurrent Clostridium difficile-associated Diarrhea: An Uncontrolled Pilot StudyJournal of Clinical Gastroenterology, 2009
- Interruption of Recurrent Clostridium difficile-Associated Diarrhea Episodes by Serial Therapy with Vancomycin and RifaximinClinical Infectious Diseases, 2007
- In Vitro Activity and Fecal Concentration of Rifaximin after Oral AdministrationAntimicrobial Agents and Chemotherapy, 2000