A Phase 4 interventional study of Rifaximin and Placebo in Clostridium Difficile Infection, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-14.
Sponsored by University of Nottingham · Phase 4, Interventional, and Prevention
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
310 studies on the registry are indexed under Clostridium Infections; 50 are open to participants now.
This study's enrollment of 151 is above the median of 65 across 233 interventional studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
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Exclusion criteria:
Identical looking tablet
Drug: Placebo
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
Also known as: Xifaxanta™
Tablets
Difference in % relapse between Rifaximin and placebo at 12 weeks
The difference in % relapse between Rifaximin and placebo at 12 weeks
Time frame: 12 weeks
Proportion relapsed, re-hospitalisation and bowel symptoms
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
Time frame: 12 weeks - 6 months
Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University of Nottingham