MedPath

Rifaximin in the prevention of Clostridium Difficile diarrhoea recurrence.

Phase 1
Conditions
C.Difficile antibiotic-associated diarrhoeal infection
Therapeutic 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
Inclusion Criteria

-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

Exclusion Criteria

-Pregnant or breast feeding

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath