E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
C.Difficile antibiotic-associated diarrhoeal infection |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To look at whether a course of Rifaximin after a patient has been successfully treated for C.difficile diarrhoeal infection with a standard course of antibiotics can reduce the rate of the infection returning (recurrence) |
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E.2.2 | Secondary objectives of the trial |
To look at the effects of Rifaximin on: -Bowel symptoms during the 12 weeks after start of treatment -Risk of infection recurrence at 6 months after start of the trial. -To collect qualitative data on patient experience in taking part in trial which we can use in the design of future larger trials. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal exclusion criteria |
-Pregnant or breast feeding |
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E.5 End points |
E.5.1 | Primary end point(s) |
The difference in % relapse between Rifaximin and placebo at 12 weeks will be assessed using a Generalised Linear Model (GLM) of Binomial family and identity Link, adjusting for centre |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The percentage of patients who relapse at 3 months on the active versus placebo. |
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E.5.2 | Secondary end point(s) |
Clinical: 1)Stool frequency and consistency during 12 weeks after start of treatment. 2) Length of stay where relevant 3) Rehospitalisation for CDAD within 6 months of start of therapy Microbiological: These exploratory assessments will be made at 0, 4 and 12 weeks after starting rifaximin or placebo. They will include: 1) Assessment of metabolic activity from pH and SCFA concentrations 2) Percentage C.difficile positive (cultured earlier if relapse). 3) Number of spores as assessed from colony counts after heat shock treatment of stool. 4) Differences in microbiological profile as assessed using the HIT chip which provides quantification for over 400 separate microbial species. 5)Antibody response to C. difficile |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial will be defined as the last participant last visit. The last scheduled visit is 6 months post-randomisation. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |