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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: Rifaximin Drug: Placebo Phase 4

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised Placebo Controlled Trial of "Follow on" Rifaximin for the Prevention of Relapse of Clostridium Associated Diarrhoea
Study Start Date : December 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Rifaximin

Arm Intervention/treatment
Placebo Comparator: Placebo
Identical looking tablet
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),
Drug: Rifaximin
Other Name: Xifaxanta™

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01670149

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United Kingdom
Nottingham Clinical Trials Unit (NCTU), Queen's Medical Centre
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
National Institute for Health Research, United Kingdom
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Principal Investigator: Aida Jawhari, MD Nottingham University Hospitals NHS Trust
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Nottingham Identifier: NCT01670149    
Other Study ID Numbers: 12072
2012-003205-10 ( EudraCT Number )
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Nottingham:
Clostridium difficile
Additional relevant MeSH terms:
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Clostridium Infections
Signs and Symptoms, Digestive
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents