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

August 17, 2012
January 14, 2014
December 2012
June 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01670149 on ClinicalTrials.gov Archive Site
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
Bowel symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary endpoints:

Clinical:

  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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Clostridium Difficile Infection
  • Drug: Rifaximin
    Tablets
    Other Name: Xifaxanta™
  • Drug: Placebo
    Other Name: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
June 2015
June 2015   (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. 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
Both
18 Years and older
No
Contact: Aida Jawhari, MD +441159249924 ext 66086 aida.jawhari@nuh.nhs.uk
Contact: Robin C Spiller, MD 1158231090 robin.spiller@nottingham.ac.uk
United Kingdom
 
NCT01670149
12072, 2012-003205-10
Yes
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
January 2014

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