Intestinal flora therapy or antibiotics for primary Clostridium difficile infectio

Phase 1

• Conditions: Clostridium difficile infection; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-004580-31-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-02
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 188

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 188
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 188

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: To investigate if fecal microbiota transplantation is non-inferior to vancomycin to achieve clinical cure of primary Clostridium difficile infection.<br> ;Secondary Objective: Identification of adverse effects related to fecal microbiota transplantation in primary C. difficile infection.;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.;Timepoint(s) of evaluation of this end point: Day 60 after study enrollment.

Secondary Outcome Measures

Name	Time	Method
<br> 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).<br> 2. Proportion of patients with adverse events.<br> 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.<br> 4. Health-economic analysis of the two compared treatment modalities<br> ;<br> Timepoint(s) of evaluation of this end point: 1. Day 60 after study enrollment.<br> 2. Day 60 and 365 after study enrollment<br> 3. Day 365 after study enrollment.<br> 4. Day 365 after study enrollment.<br>