E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Clostridium difficile infection |
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E.1.1.1 | Medical condition in easily understood language |
Clostridium difficile infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
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 investigate if fecal microbiota transplantation is non-inferior to vancomycin to achieve clinical cure of primary Clostridium difficile infection.
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E.2.2 | Secondary objectives of the trial |
Identification of adverse effects related to fecal microbiota transplantation in primary C. difficile infection. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients, ≥18 years with primary C. difficile infection defined as:
•Diarrhea as defined by the WHO (≥3 loose stools per day), and
•Positive stool test for toxin producing C. difficile, and
•No evidence of previous C. difficile infection during 365 days before enrolment.
Written informed consent |
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E.4 | Principal exclusion criteria |
Presence of other stool pathogens known to cause diarrhea.
Ongoing or scheduled (e.g. surgery prophylaxis) antibiotic treatment for other infections that cannot be stopped for 12 hours after treatment allocation.
Inflammatory bowel disease or microscopic colitis.
< 3 months life expectancy.
Serious immunodeficiency, defined as one of the following:
-Ongoing or recent chemotherapy and current or expected neutropenia with neutrophil count of < 500/µL.
-Active severe immunocompromising disease.
Inability to comply with protocol requirements.
Need of intensive care or American Society of Anesthesiologists (ASA) Physical Status classification IV or V.
Known irritable bowel syndrome, diarrheal type.
Pregnancy or nursing.
Known or suspected toxic megacolon or ileus.
Total or subtotal colectomy, ileostomy or colonostomy.
Known hypersensitivity or other contraindications to vancomycin. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent Clostridium difficile infection during 60 days after treatment start, with the assigned treatment alone. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 60 after study enrollment. |
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E.5.2 | Secondary end point(s) |
1. Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, with or without the need of additional treatment (FMT, metronidazole or vancomycin).
2. Proportion of patients with adverse events.
3. Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, and without recurrent C. difficile infection within 365 days after treatment start.
4. Health-economic analysis of the two compared treatment modalities
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Day 60 after study enrollment.
2. Day 60 and 365 after study enrollment
3. Day 365 after study enrollment.
4. Day 365 after study enrollment. |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Fecal microbiota transplant from healthy donors |
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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 | 10 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |