NCT01670149

Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea

A Randomised Placebo Controlled Trial of "Follow on" Rifaximin for the Prevention of Relapse of Clostridium Associated Diarrhoea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	Rifaximin	Tablets
DRUG	Placebo	Tablets

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2012-08-21
• Last updated: 2021-10-14

Locations

1 site across 1 country: United Kingdom