NCT01670149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

3.6 years

First QC Date

August 17, 2012

Last Update Submit

October 5, 2021

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficileDiarrhoeaRifaximin

Outcome Measures

Primary Outcomes (1)

  • Difference in % relapse between Rifaximin and placebo at 12 weeks

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

    12 weeks

Secondary Outcomes (1)

  • Proportion relapsed, re-hospitalisation and bowel symptoms

    12 weeks - 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Identical looking tablet

Drug: Placebo

Rifaximin , Xifaxanta™

ACTIVE COMPARATOR

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

Interventions

RifaximinDRUG

Tablets

Also known as: Xifaxanta™
Rifaximin , Xifaxanta™
PlaceboDRUG

Tablets

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (2)

  • 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: 30254135RESULT

  • 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.

    PMID: 27558181DERIVED

Related Links

MeSH Terms

Conditions

Clostridium InfectionsDiarrhea

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Aida Jawhari, MD

    Nottingham University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2012

First Posted

August 21, 2012

Study Start

December 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 14, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)