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Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea

NCT ID: NCT01670149

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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

Conditions

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Clostridium Difficile Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Identical looking tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets

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),

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

Tablets

Interventions

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Rifaximin

Tablets

Intervention Type DRUG

Placebo

Tablets

Intervention Type DRUG

Other Intervention Names

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Xifaxanta™

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aida Jawhari, MD

Role: PRINCIPAL_INVESTIGATOR

Nottingham University Hospitals NHS Trust

Locations

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

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 30254135 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27558181 (View on PubMed)

Related Links

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https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-003205-10/results

Summary results EU Clinical Trials Register

Other Identifiers

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2012-003205-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12072

Identifier Type: -

Identifier Source: org_study_id