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Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea (RAPID)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Nottingham
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01670149
First received: August 17, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Clostridium Difficile Infection
Drug: Rifaximin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Difference in % relapse between Rifaximin and placebo at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The difference in % relapse between Rifaximin and placebo at 12 weeks


Secondary Outcome Measures:
  • Proportion relapsed, re-hospitalisation and bowel symptoms [ Time Frame: 12 weeks - 6 months ] [ Designated as safety issue: No ]

    Secondary endpoints:

    Clinical:

    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

    Exploratory:

    1. Stool frequency and consistency during 12 weeks after start of treatment
    2. Microbiological assessments


Estimated Enrollment: 180
Study Start Date: December 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Identical looking tablet
Drug: Placebo
Other Name: 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
Tablets
Other Name: Xifaxanta™

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. Unable to stop chronic antibiotic use
  6. Life expectancy of <4 weeks
  7. 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)
  8. >5 days post standard therapy (metronidazole or vancomycin) for clinically diagnosed CDAD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670149

Contacts
Contact: Aida Jawhari, MD +441159249924 ext 66086 aida.jawhari@nuh.nhs.uk
Contact: Robin C Spiller, MD 1158231090 robin.spiller@nottingham.ac.uk

Locations
United Kingdom
Nottingham Clinical Trials Unit (NCTU), Queen's Medical Centre Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Contact: Nafisa Boota, BSc (Hons)    +44 (0)115 884 4924    Nafisa.Boota@nottingham.ac.uk   
Contact: Robin c Spiller, MD    +44 (0)115 8231090    robin.spiller@nottingham.ac.uk   
Principal Investigator: Aida Jawhari, MD         
Sub-Investigator: Giles Major, MD         
Sponsors and Collaborators
University of Nottingham
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Aida Jawhari, MD Nottingham University Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01670149     History of Changes
Other Study ID Numbers: 12072, 2012-003205-10
Study First Received: August 17, 2012
Last Updated: January 14, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Nottingham:
Clostridium difficile
Diarrhoea
Rifaximin

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive
Rifaximin
Anti-Infective Agents
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014