Follow-on RifAximin for the Prevention of recurrence following standard treatment of Infection with Clostridium Difficile (RAPID): a randomised placebo controlled trial. Issue 7 (25th September 2018)

• Record Type: Journal Article
• Authors: Major, Giles; Bradshaw, Lucy; Boota, Nafisa; Sprange, Kirsty; Diggle, Mathew; Montgomery, Alan; Jawhari, Aida; Spiller, Robin C
• Other Names: author non-byline.; Montgomery Alan author non-byline.; Bradshaw Lucy author non-byline.; Boota Nafisa author non-byline.; Fahy Sarah author non-byline.; Allen Rob author non-byline.; Watson John author non-byline.; Walker Sarah author non-byline.; Sprange Kirsty author non-byline.; Childs Margo author non-byline.; Bumphrey Gill author non-byline.; Simpkins Daniel author non-byline.; Whitaker Keith author non-byline.; Hodgson Sheila author non-byline.; Pharmacist Lead author non-byline.; Cook Bernie author non-byline.; Lingaya Melanie author non-byline.; Falcone Yirga author non-byline.; Diggle Mathew author non-byline.; Budd Patrick author non-byline.; Sloan Tim author non-byline.; Jalanka Jonna author non-byline.; Stevenson Emma author non-byline.; Jawhari Aida author non-byline.; Ahmad Saqib author non-byline.; Foreman Helen author non-byline.; Garratt Jill author non-byline.; Pyke Shirley author non-byline.; Rorison Brian author non-byline.; Patel Mina author non-byline.; 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Fairweather Mark author non-byline.; Lancaster Nicola author non-byline.; Hone Sarah author non-byline.; Commey Thelma author non-byline.; Allcock Clare author non-byline.; Smith Jacqueline author non-byline.; Mohankumar Lakshimpriya author non-byline.; Gidda Ranjit author non-byline.; Ishaq Sauid author non-byline.; Merotra Susan author non-byline.; Stacey Danielle author non-byline.; Das Dave author non-byline.; Taylor Emma author non-byline.; Foley Gail author non-byline.; Curtis Janette author non-byline.; Orrell Lucy author non-byline.; Holland Maureen author non-byline.; Taylor Moira author non-byline.; Scanlon Sarah author non-byline.; Graham Susan author non-byline.; Mahmood Zahid author non-byline.; Dugh Parveen author non-byline.; Gyawali Pranab author non-byline.; Tsui Salina author non-byline.; McClusky Theresa author non-byline.; Wiseman WanTei author non-byline.; Rommel Butwana author non-byline.; Patel Meera author non-byline.; Premchand Purushothaman author non-byline.; Spencer Kevin author non-byline.; Davis Rob author non-byline.; Goodye Sacha author non-byline.; Rahman Anisur author non-byline.; Witele Eric author non-byline.; Notcheva Gaynor author non-byline.; Chung-Faye Guy author non-byline.; Flanagan Joanna author non-byline.; Mandar Kirandip author non-byline.; Choong Lee Meng author non-byline.; Adedeji Oluwafunmilayo author non-byline.; Tashi Surabhi author non-byline.;
• Is Part Of: Gut. Volume 68:Issue 7(2019)
• Page Start: 1224
• Page End: 1231
• Publication Date: 2018-09-25
• Subjects: diarrhoea -- enteric infections -- infective colitis -- inflammation; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2018-316794
• Languages: English
• ISSNs: 0017-5749

Abstract

Abstract : Background: Clostridium difficile infection (CDI) recurs after initial treatment in approximately one in four patients. A single-centre pilot study suggested that this could be reduced using 'follow-on' rifaximin treatment. We aimed to assess the efficacy of rifaximin treatment in preventing recurrence. Methods: A multisite, parallel group, randomised, placebo controlled trial recruiting patients aged ≥18 years immediately after resolution of CDI through treatment with metronidazole or vancomycin. Participants received either rifaximin 400 mg three times a day for 2 weeks, reduced to 200 mg three times a day for a further 2 weeks or identical placebo. The primary endpoint was recurrence of CDI within 12 weeks of trial entry. Results: Between December 2012 and March 2016, 151 participants were randomised to either rifaximin or placebo. Primary outcome data were available on 130. Mean age was 71.9 years (SD 15.3). Recurrence within 12 weeks was 29.5% (18/61) among participants allocated to placebo compared with 15.9% (11/69) among those allocated to rifaximin, a difference between groups of 13.7% (95% CI −28.1% to 0.7%, p=0.06). The risk ratio was 0.54 (95% CI 0.28 to 1.05, p=0.07). During 6-month safety follow-up, nine participants died in each group (12%). Adverse event rates were similar between groups. Conclusion: While 'follow-on' rifaximin after CDI appeared to halve recurrence rate, we failed to reach our recruitment target in this group of frail elderly patients, so the estimated effect of rifaximin lacks precision. A meta-analysis including a previous trial suggests that rifaximin may be effective; however, further, larger confirmatory studies are needed.