Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nottingham
• Collaborator: National Institute for Health Research, United Kingdom
• Treatments: Rifamycins; Rifaximin

Criteria

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