Recurrent infection with Clostridium Difficile MedDRA version: 19.0 Level: LLT Classification code 10072994 Term: Clostridium difficile infection recurrence System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Vancocin
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: vancomycin hydrochloride
Other descriptive name: VANCOMYCIN HYDROCHLORIDE
Sponsors
Department of Medicine, Zealand University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years - Recurrent Clostridium Difficile infection with diarrhea (or toxic megacolon) and verified presence of Clostridium difficile in faeces, and/or pseudomembranoues colitis, diagnosed within 90 days of the last episode of Clostridium difficile infection - Having received at least one earlier specific treatment for Clostridium difficile infection (at least 10 days of vancomycin with at least 125 mg 4 times daily or at least 10 days of metronidazol with at least 500 mg 3 times a day) - The patient is allowed to have started treatment with oral vancomycin within 7 days, but does not need to have started treatment with oral vancomycin - Being able to give informed consent after information in danish 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: - Terminal illness with a life expectancy less than 3 months. - Allergy to vancomycin. - Other clinically significant gastrointestinal infections. - Other antibacterial treatment planned for a duration of more than 14 days from time of inclusion (for example for spondylodiscitis, endocarditis or tuberculosis). - Gastrointestinal disease, which can cause diarrhea or in other way affects symptom reporting, including patients that have undergone colectomy. - Severely compromised immune system, which makes faecal microbiota transplantation/rectal bacteriotherapy releatively contraindicated by clinical judgement. - Pregnancy, planned pregnancy or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the treatment effect of rectal bacteriotherapy instillation (RBI) and faecal microbiota transplantation /FMT) against the standard antibotic treatment with vancomycin for patients with recurrent Clostridium Difficile infection in a randomised controlled trial;Secondary Objective: Not applicable;Primary end point(s): Clinical cure, defined as the absence of Clostridium Difficile infection, in 90 days after the end of treatment ; Timepoint(s) of evaluation of this end point: A interim analysis will be done when 30 patients in each treatment group has been followed for 90 days. Final evaluation will be done after 180 days of follow-up after treatment on all patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Evaluation after 180 days of follow-up ; Secondary end point(s): - Early (Between 14-30 days after) and late (after 31-180 days) recurrence of CDI after end of treatment. - Days with diarrhea in week 1, 4, 8, 12 after end of treatment. - CDI-associated hospitalization and hospitalization of other causes in the 180 days of follow-up after end of treatment. - CDI-associated outpatient hospital contact and outpatient hospital contact of other causes in the 180 days of follow-up after end of treatment. - CDI-associated mortality and all-cause mortality 30, 90 and 180 days after end of treatment. - CDI-associated morbidity, CDI-associated mortality and all-cause mortality 3 years and 5 years after end of treatment (as part of a prospective registerbased study after end of trial). Subgroup analyzes: - The effect of treatment (primary endpoint) in the three treatment arms by stratification of patients in groups with 1 recurrence and with =2 recurrences. - The effect of treatment (primary endpoint), depending on the CD strain - respectively toxin B CDI cases, toxin B plus binary toxin CDI cases and CD027 CDI cases. - Treatment effect (primary endpoint), depending on the patients' serum level of antibodies to Toxin A and B, anti-TcdA and anti-TcdB, at inclusion. Other analyzes: - Registration of antibiotic treatments and temporal association with new recurrences of CDI in 180 days after the end of treatment. - Identification of demographic and clinical factors associated with treatment success / failure. - Characterization of the intestinal microbiota before and after FMT / RBI, in conjunction with characterization of intestinal microbiota in donors / RBI mixture. This will only be carried out i | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Information
Department of Medicine
Outcome results
None listed