Clostridium difficile infection MedDRA version: 20.0 Level: LLT Classification code 10012748 Term: Diarrhoea, Clostridium difficile System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Vancomicina
Pharmaceutical Form: Concentrate for concentrate for solution for infusion
INN or Proposed INN: VANCOMYCIN
CAS Number: 1404-90-6
Current Sponsor code: 73785
Concentration unit:
Sponsors
Emilio Bouza Santiago
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women • Age> 18 years • That they agree and are able to give their informed consent (patient or legal representative). • Microbiological Diagnosis of toxigenic Clostridium difficile (ICD) infection with direct positive toxin test and diarrhea (> 3 bowel movements / 24 hours) or colonoscopic or histopathological findings that demonstrate pseudomembranous colitis within the first 72 hours before receiving the first dose of treatment. • Patients who are in a first episode of ICD that meet criteria of risk of poor outcome. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Intensive care unit admission • Pregnant or breatsfeeding patients at the signing of consent. • Patients with neutropenia (with a total neutrophil count <0.5 x 109 / L) • Enteritis by Salmonella, Shigella, E. coli 0157H7, Yersinia or Campylobacter. • Severe baseline disease whose expected survival is less than three months. • Patients with Child C cirrhosis • Patients with current or recent (<3 months) treatment with antineoplastic agents or immunosuppressive medication (including but not limited to monoclonal antibodies to B and T cells, anti-TNF agents, antimetabolites (azathioprine, 6-mercaptopurine), inhibitors of calcineurin (tacrolimus, cyclosporine) mycophenolate mofetil. • Patients with a history of severe allergy (anaphylactic) to food. • Patients with known allergy or hypersensitivity to vancomycin or fidaxomicin. • Patients with fever on the day planned for bacteriotherapy • Gastroparesis • known Chronic aspiration • Dysfunction when swallowing or not oral-motor coordination • Patients with any condition, which in the opinion of their physician, bacteriotherapy may endanger the health of the patient. • Administration of any investigational antibiotic drug during the 30 days prior to inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the recurrence rate to treatment with bacteriotherapy versus conventional treatment with vancomycin;Secondary Objective: Compare the response rate and recurrences between the following subgroups: patients with ICD by "hypervirulent" ribotipos strains such as 027. To compare the evolution in economic and comorbidity, including the length of hospital stay and hospital admission rates among patients receiving treatment with bacteriotherapy and those receiving conventional treatment with Vancomycin. • To compare the composition of intestinal microbiota before and after treatment among patients receiving treatment with bacteriotherapy and those receiving conventional vancomycin treatment. • To compare the efficacy of treatment with bacteriotherapy against conventional treatment with oral vancomycin.;Primary end point(s): poor outcome (therapeutic failure, progression of infection to complicated severe forms, recurrence or mortality associated with infection);Timepoint(s) of evaluation of this end point: every study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Resolution of the episode, patient well-being and hospital stay;Timepoint(s) of evaluation of this end point: Visits: post treatment visit, early follow-up day 30, late follow up day 60 | — |
Countries
Spain
Contacts
Public ContactElena Reigadas
Emilio Bouza Santiago
Outcome results
None listed