Rifaximin in the prevention of Clostridium Difficile diarrhoea recurrence.
- Conditions
- C.Difficile antibiotic-associated diarrhoeal infectionTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-003205-10-GB
- Lead Sponsor
- niversity of Nottingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 151
-Men/Women aged 16+ years -Successful treatment of clinically diagnosed CDAD using standard therapy (metronidazole or vancomycin given according to standard local hospital guidelines and course completed within the last 5 days). -Successful treatment of CDAD using standard therapy (metronidazole or vancomycin)given according to standard local hospital guidelines. -Able to stop chronic antibiotic use -Women of child bearing potential willing and able to use at least one highly effective contraceptive method throughout the study. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as: implants, injectables, combined oral contraceptives, sexual abstinence or vasectomised partner.
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 115
-Pregnant or breast feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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