<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01670149</url>
  </required_header>
  <id_info>
    <org_study_id>12072</org_study_id>
    <secondary_id>2012-003205-10</secondary_id>
    <nct_id>NCT01670149</nct_id>
  </id_info>
  <brief_title>Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea</brief_title>
  <acronym>RAPID</acronym>
  <official_title>A Randomised Placebo Controlled Trial of &quot;Follow on&quot; Rifaximin for the Prevention of Relapse of Clostridium Associated Diarrhoea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clostridium difficile associated diarrhoea is an important cause of morbidity in patients&#xD;
      treated with antibiotics, especially in hospital. Clinical relapse occurs after up to 30% of&#xD;
      initially successful treatments for colitis. Preliminary reports suggest that Rifaximin, a&#xD;
      poorly absorbed antibiotic used to treat travellers diarrhoea can prevent relapse. We plan to&#xD;
      carry out a randomised placebo controlled trial to test the hypothesis that Rifaximin given&#xD;
      in a reducing dose over 4 weeks after successful treatment will reduce the relapse rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims i) To examine efficacy of a follow-on course of Rifaximin given after a successful&#xD;
      initial course of standard treatment, in the prevention of relapse in C. difficile associated&#xD;
      diarrhoea (CDAD).&#xD;
&#xD;
      ii) To examine changes in faecal microbiota in patients given Rifaximin vs. Placebo.&#xD;
&#xD;
      Treatment 4 weeks treatment with Rifaximin or Placebo tablets. Tapering dose starting with 2&#xD;
      x 200mg tablets three times a day (total = 1.2g per day) for the 1st 2 weeks, reduced to 1 x&#xD;
      200mg tablet three times a day (total = 0.6g per day) for the 2nd 2 weeks.&#xD;
&#xD;
      Primary endpoint: The difference in % relapse between Rifaximin and placebo at 12 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in % relapse between Rifaximin and placebo at 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>The difference in % relapse between Rifaximin and placebo at 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion relapsed, re-hospitalisation and bowel symptoms</measure>
    <time_frame>12 weeks - 6 months</time_frame>
    <description>Secondary endpoints:&#xD;
Clinical:&#xD;
Proportion with relapse of CDAD within 6 months&#xD;
Proportion re-hospitalised for CDAD within 6 months&#xD;
Length of in-hospital stay following start of treatment&#xD;
Exploratory:&#xD;
Stool frequency and consistency during 12 weeks after start of treatment&#xD;
Microbiological assessments</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Clostridium Difficile Infection</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Identical looking tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rifaximin , Xifaxanta™</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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),</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifaximin</intervention_name>
    <description>Tablets</description>
    <arm_group_label>Rifaximin , Xifaxanta™</arm_group_label>
    <other_name>Xifaxanta™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Men / Women aged 18 and over (We will also include those adults who lack mental&#xD;
             capacity for whom we have a legal representative)&#xD;
&#xD;
          2. Successful treatment of clinically diagnosed CDAD using standard therapy&#xD;
             (metronidazole or vancomycin given according to standard local hospital guidelines).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Woman of child bearing potential and not willing to use at least one highly effective&#xD;
             contraceptive method throughout the study&#xD;
&#xD;
          2. Male with spouse/partner of child bearing potential and not willing to use condoms&#xD;
&#xD;
          3. Pregnant or breast feeding&#xD;
&#xD;
          4. Unable to swallow tablets&#xD;
&#xD;
          5. Life expectancy of &lt;4 weeks&#xD;
&#xD;
          6. Hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or&#xD;
             rifabutin) or to any of its excipients (Tablet core: Sodium starch glycolate type A,&#xD;
             glycerol distearate, colloidal anhydrous, silica, talc and microcrystalline cellulose.&#xD;
             Tablet coating: hypromellose, titanium dioxide (E171), disodium edentate, propylene&#xD;
             glycol and red iron oxide E172)&#xD;
&#xD;
          7. &gt;5 days post standard therapy (metronidazole or vancomycin) for clinically diagnosed&#xD;
             CDAD&#xD;
&#xD;
          8. Taking ciclosporin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aida Jawhari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nottingham University Hospitals NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nottingham Clinical Trials Unit (NCTU), Queen's Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-003205-10/results</url>
    <description>Summary results EU Clinical Trials Register</description>
  </link>
  <results_reference>
    <citation>Major G, Bradshaw L, Boota N, Sprange K, Diggle M, Montgomery A, Jawhari A, Spiller RC; RAPID Collaboration Group. Follow-on RifAximin for the Prevention of recurrence following standard treatment of Infection with Clostridium Difficile (RAPID): a randomised placebo controlled trial. Gut. 2019 Jul;68(7):1224-1231. doi: 10.1136/gutjnl-2018-316794. Epub 2018 Sep 25.</citation>
    <PMID>30254135</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>October 5, 2021</last_update_submitted>
  <last_update_submitted_qc>October 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clostridium difficile</keyword>
  <keyword>Diarrhoea</keyword>
  <keyword>Rifaximin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clostridium Infections</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rifaximin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01670149
org study id: 12072
secondary id: 2012-003205-10
nct id: NCT01670149
lead sponsor: 
collaborator: 
has dmc: Yes
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Difference in % relapse between Rifaximin and placebo at 12 weeks
time frame: 12 weeks
description: The difference in % relapse between Rifaximin and placebo at 12 weeks
measure: Proportion relapsed, re-hospitalisation and bowel symptoms
time frame: 12 weeks - 6 months
description: Secondary endpoints:
Clinical:
Proportion with relapse of CDAD within 6 months
Proportion re-hospitalised for CDAD within 6 months
Length of in-hospital stay following start of treatment
Exploratory:
Stool frequency and consistency during 12 weeks after start of treatment
Microbiological assessments
arm group label: Placebo
arm group type: Placebo Comparator
description: Identical looking tablet
arm group label: Rifaximin , Xifaxanta™
arm group type: Active Comparator
description: 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 type: Drug
intervention name: Rifaximin
description: Tablets
arm group label: Rifaximin , Xifaxanta™
other name: Xifaxanta™
intervention type: Drug
intervention name: Placebo
description: Tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aida Jawhari, MD
role: Principal Investigator
affiliation: Nottingham University Hospitals NHS Trust
facility: 
country: United Kingdom
url: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-003205-10/results
description: Summary results EU Clinical Trials Register
citation: Major G, Bradshaw L, Boota N, Sprange K, Diggle M, Montgomery A, Jawhari A, Spiller RC; RAPID Collaboration Group. Follow-on RifAximin for the Prevention of recurrence following standard treatment of Infection with Clostridium Difficile (RAPID): a randomised placebo controlled trial. Gut. 2019 Jul;68(7):1224-1231. doi: 10.1136/gutjnl-2018-316794. Epub 2018 Sep 25.
PMID: 30254135
responsible party type: Sponsor
mesh term: Clostridium Infections
mesh term: Diarrhea
mesh term: Rifaximin
sharing ipd: No