Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea

Phase 4

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Drug: Placebo; Drug: Rifaximin

• Registration Number: NCT01670149
• Lead Sponsor: University of Nottingham

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

Study Timeline

• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-21
• Study Start: 2012-12
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Identical looking tablet
Rifaximin , Xifaxanta™	Rifaximin	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),

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion relapsed, re-hospitalisation and bowel symptoms	12 weeks - 6 months	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

Trial Locations

Locations (1)

Nottingham Clinical Trials Unit (NCTU), Queen's Medical Centre; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom