Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea (RAPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01670149
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : May 8, 2017
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham

August 17, 2012
August 21, 2012
May 8, 2017
December 2012
July 2016   (Final data collection date for primary outcome measure)
Difference in % relapse between Rifaximin and placebo at 12 weeks [ Time Frame: 12 weeks ]
The difference in % relapse between Rifaximin and placebo at 12 weeks
Same as current
Complete list of historical versions of study NCT01670149 on Archive Site
Proportion relapsed, re-hospitalisation and bowel symptoms [ Time Frame: 12 weeks - 6 months ]

Secondary endpoints:


  1. Proportion with relapse of CDAD within 6 months
  2. Proportion re-hospitalised for CDAD within 6 months
  3. Length of in-hospital stay following start of treatment


  1. Stool frequency and consistency during 12 weeks after start of treatment
  2. Microbiological assessments
Bowel symptoms [ Time Frame: 12 weeks ]

Secondary endpoints:


  1. Bowel symptoms Average daily stool frequency and consistency for each month after start of treatment will be compared for active versus placebo using Students t Test assuming a normal distribution which is likely given the large numbers. In the event of a non-normal distribution the Mann-Whitney U test will be used. A similar approach will be taken for comparing
  2. Length of stay on active versus placebo
  3. The difference in relapse of CDAD within 6 months of start of therapy will be assessed using a continuity-corrected chi-squared statistic or Fisher's exact test
Not Provided
Not Provided
Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea
A Randomised Placebo Controlled Trial of "Follow on" Rifaximin for the Prevention of Relapse of Clostridium Associated Diarrhoea
Clostridium difficile associated diarrhoea is an important cause of morbidity in patients treated with antibiotics, especially in hospital. Clinical relapse occurs after up to 30% of initially successful treatments for colitis. Preliminary reports suggest that Rifaximin, a poorly absorbed antibiotic used to treat travellers diarrhoea can prevent relapse. We plan to carry out a randomised placebo controlled trial to test the hypothesis that Rifaximin given in a reducing dose over 4 weeks after successful treatment will reduce the relapse rate.

Aims i) To examine efficacy of a follow-on course of Rifaximin given after a successful initial course of standard treatment, in the prevention of relapse in C. difficile associated diarrhoea (CDAD).

ii) To examine changes in faecal microbiota in patients given Rifaximin vs. Placebo.

Treatment 4 weeks treatment with Rifaximin or Placebo tablets. Tapering dose starting with 2 x 200mg tablets three times a day (total = 1.2g per day) for the 1st 2 weeks, reduced to 1 x 200mg tablet three times a day (total = 0.6g per day) for the 2nd 2 weeks.

Primary endpoint: The difference in % relapse between Rifaximin and placebo at 12 weeks

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Clostridium Difficile Infection
  • Drug: Rifaximin
    Other Name: Xifaxanta™
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Identical looking tablet
    Intervention: Drug: Placebo
  • Active Comparator: Rifaximin , Xifaxanta™
    2 weeks of Rifaximin 400mg thrice daily then 2 weeks of Rifaximin 200mg thrice daily Modified Xifaxanta™ (rifaximin film-coated tablet) manufactured by Alfa Wasermann (AW),
    Intervention: Drug: Rifaximin
Stevenson EC, Major GA, Spiller RC, Kuehne SA, Minton NP. Coinfection and Emergence of Rifamycin Resistance during a Recurrent Clostridium difficile Infection. J Clin Microbiol. 2016 Nov;54(11):2689-2694. Epub 2016 Aug 24.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2016
July 2016   (Final data collection date for primary outcome measure)

Inclusion criteria:

  1. Men / Women aged 18 and over (We will also include those adults who lack mental capacity for whom we have a legal representative)
  2. Successful treatment of clinically diagnosed CDAD using standard therapy (metronidazole or vancomycin given according to standard local hospital guidelines).

Exclusion criteria:

  1. Woman of child bearing potential and not willing to use at least one highly effective contraceptive method throughout the study
  2. Male with spouse/partner of child bearing potential and not willing to use condoms
  3. Pregnant or breast feeding
  4. Unable to swallow tablets
  5. Life expectancy of <4 weeks
  6. Hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or rifabutin) or to any of its excipients (Tablet core: Sodium starch glycolate type A, glycerol distearate, colloidal anhydrous, silica, talc and microcrystalline cellulose. Tablet coating: hypromellose, titanium dioxide (E171), disodium edentate, propylene glycol and red iron oxide E172)
  7. >5 days post standard therapy (metronidazole or vancomycin) for clinically diagnosed CDAD
  8. Taking ciclosporin
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
2012-003205-10 ( EudraCT Number )
Not Provided
Plan to Share IPD: No
University of Nottingham
University of Nottingham
National Institute for Health Research, United Kingdom
Principal Investigator: Aida Jawhari, MD Nottingham University Hospitals NHS Trust
University of Nottingham
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP