Clostridium Difficile Infection
Conditions
Brief summary
Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection
Interventions
OTHERFecal microbiota transplantation
FMT follows 4-10 days of vancomycin 125 mg x 4 daily
DRUGFidaxomicin
Fidaxomicin 200 mg x 2 daily for 10 days
DRUGVancomycin
Vancomycin 125 mg x 4 daily for 10 days
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1\. Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin
Exclusion criteria
1. Pregnancy or breastfeeding 2. Does not speak or understand the Danish language 3. Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin 4. fulminant colitis which contraindicates medical treatment 5. physician's evaluation that the patient cannot tolerate project inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment | 8 weeks | Global resolution is defined as combined clinical and microbiological resolution, without need for rescue FMT or colectomy. Clinical resolution is absence of abdominal pain (pain score 0 (no pain), 1 (mild pain), 2 (moderate pain), 3 (severe pain)) and less than 3 bowel movements of Bristol 5 or lower, per day. Microbiological resolution is negative Clostridium difficile test 8 weeks after finishing allocated treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with clinical resolution 8 weeks after primary treatment | 8 weeks | Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 8 weeks after finishing allocated treatment, without need for rescue FMT or colectomy |
| Number of patients with clinical resolution 26 weeks after primary treatment | 26 weeks | Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy |
| Number of patients with microbiological resolution week 1 | 1 week | Microbiological resolution (negative Clostridium difficile PC test) 1 weeks after finishing allocated treatment, without need for rescue FMT or colectomy |
| Number of patients with microbiological resolution week 8 | 8 weeks | Microbiological resolution (negative Clostridium difficile PC test) 8 weeks after finishing allocated treatment, without need for rescue FMT or colectomy |
| Number of patients with clinical resolution 1 week after primary treatment | 1 week | Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 1 week after finishing allocated treatment |
| Number of patients with global resolution (Clinical and microbiological resolution) week 1 | 1 week | Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) and microbiological resolution(negative Clostridium difficile test) 1 week after finishing allocated treatment, without need for rescue FMT or colectomy |
| Number of patients with global resolution (Clinical and microbiological resolution) week 26 | 26 weeks | Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) and microbiological resolution(negative Clostridium difficile test) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy |
| Numerical change in quality of life (EQ5D-3L) week 8 and 26 | 8 and 26 weeks | EQ5D-3L (www.euroqol.com) measures self-reported quality of life in 5 dimensions (each three levels), rendering score from 5 (lowest and best) to 15 (highest and worst) plus an overall reporting of general well being (0, lowest, worst to 100, highest, best). Scoring is obtained week 0,8,26 after randomization. Numerical changes are documented and compared using non-parametric statistics |
| Microbiota pattern changes 1, 8 and 26 weeks | 1, 8 and 26 weeks | Microbiota profiling, 16S rRNA, absence or presence of specific genera |
| Number of patients with microbiological resolution week 26 | 26 weeks | Microbiological resolution (negative Clostridium difficile PC test) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy |
Countries
Denmark
Outcome results
None listed