Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea

Clostridium Difficile Infection Clinical Trial

— RAPID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670149
• Other study ID #: 12072
• Secondary ID: 2012-003205-10
• Status: Completed
• Phase: Phase 4
• Start date: December 2012
• Est. completion date: July 2016

Study information

• Verified date: October 2021
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Diarrhea

Intervention

Drug:
• Rifaximin
Tablets
• Placebo
Tablets

Locations

Country	Name	City	State
United Kingdom	Nottingham Clinical Trials Unit (NCTU), Queen's Medical Centre	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 randomi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in % relapse between Rifaximin and placebo at 12 weeks	The difference in % relapse between Rifaximin and placebo at 12 weeks	12 weeks
Secondary	Proportion relapsed, re-hospitalisation and bowel symptoms	Secondary endpoints: Clinical: Proportion with relapse of CDAD within 6 months; Proportion re-hospitalised for CDAD within 6 months; Length of in-hospital stay following start of treatment; Exploratory: Stool frequency and consistency during 12 weeks after start of treatment; Microbiological assessments	12 weeks - 6 months

External Links

•   Summary results EU Clinical Trials Register