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Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea (RAPID)

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Rifaximin
Placebo
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Infection focused on measuring Clostridium difficile, Diarrhoea, Rifaximin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nottingham Clinical Trials Unit (NCTU), Queen's Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Rifaximin , Xifaxanta™

Arm Description

Identical looking tablet

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),

Outcomes

Primary Outcome Measures

Difference in % relapse between Rifaximin and placebo at 12 weeks
The difference in % relapse between Rifaximin and placebo at 12 weeks

Secondary Outcome Measures

Proportion relapsed, re-hospitalisation and bowel symptoms
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

Full Information

First Posted
August 17, 2012
Last Updated
October 5, 2021
Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT01670149
Brief Title
Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea
Acronym
RAPID
Official Title
A Randomised Placebo Controlled Trial of "Follow on" Rifaximin for the Prevention of Relapse of Clostridium Associated Diarrhoea
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
Clostridium difficile, Diarrhoea, Rifaximin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical looking tablet
Arm Title
Rifaximin , Xifaxanta™
Arm Type
Active Comparator
Arm 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(s)
Rifaximin
Other Intervention Name(s)
Xifaxanta™
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
Difference in % relapse between Rifaximin and placebo at 12 weeks
Description
The difference in % relapse between Rifaximin and placebo at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Proportion relapsed, re-hospitalisation and bowel symptoms
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
Time Frame
12 weeks - 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Men / Women aged 18 and over (We will also include those adults who lack mental capacity for whom we have a legal representative) Successful treatment of clinically diagnosed CDAD using standard therapy (metronidazole or vancomycin given according to standard local hospital guidelines). Exclusion criteria: Woman of child bearing potential and not willing to use at least one highly effective contraceptive method throughout the study Male with spouse/partner of child bearing potential and not willing to use condoms Pregnant or breast feeding Unable to swallow tablets Life expectancy of <4 weeks 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) >5 days post standard therapy (metronidazole or vancomycin) for clinically diagnosed CDAD Taking ciclosporin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aida Jawhari, MD
Organizational Affiliation
Nottingham University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham Clinical Trials Unit (NCTU), Queen's Medical Centre
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30254135
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.
Results Reference
result
PubMed Identifier
27558181
Citation
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. doi: 10.1128/JCM.01025-16. Epub 2016 Aug 24.
Results Reference
derived
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-003205-10/results
Description
Summary results EU Clinical Trials Register

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Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea

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