Vancomycin-resistant Enterococci carriage Antibiotic resistance Dragerschap vancomycine-resistente Enterococ Antibiotica resistentie
Conditions
Interventions
Bowel lavage, followed by infusion of 198 mL of a standardized stool suspension through a duodenal tube (FMT)
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: - Adult patients (≥18 years old at date of inclusion) - Ability to provide informed consent - Documented intestinal carriage of VRE by stool culture at baseline (visit 0)
Exclusion criteria
Exclusion criteria: - Difficult / impossible follow-up - Pregnancy or planned pregnancy or breastfeeding - Allergy or other contraindication to colofort - Severe food allergy (anaphylaxis, urticaria) - Recurrent aspirations / chronic dysphagia or anatomic contraindication to the placement of a nasoduodenal tube - Congestive heart failure class III-IV - Estimated life expectancy < 6 months - Current hospitalization in an Intensive Care Unit - Treatment with any systemic antibiotic on the day of inclusion - Severe immunodeficiency - Systemic chemotherapy ≤ 30 days from baseline or planned chemotherapy within the next 12 months - Human Immunodeficiency Virus (HIV) with CD4 count < 250/mcl - Neutropenia with an absolute neutrophil count <1000/µL - Hematopoietic stem cell transplant recipients - Solid organ transplant recipients - Inflammatory Bowel Disease (Crohn’s disease, Colitis Ulcerosa) - Estimated glomerular filtration rate (CKD-EPI) < 15 ml/min/1.73m2 - Unavailability of compatible FMT preparation (with regard to donor / recipient CMV, EBV and Toxoplasma serology)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be intestinal carriage of VRE (absence/presence by stool culture of VRE) 6 months / 170 - 185 days after intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint will be intestinal carriage of VRE (absence/presence by stool culture of VRE) 12 months / 355 - 375 days after intervention. | — |
Contacts
Public ContactE. Rademaker
Division Laboratory and Pharmacy, Medische Microbiologie, University Medical Center Utrecht | Room number: Str. 6.101
Outcome results
None listed