Eradication of antibiotic-resistant bacteria through antibiotics and fecalbacteriotherapy.

Conditions: Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Intestinal colonization with extended-spectrum beta-lactamse or carbapenemase producing enterobacteriaceae
MedDRA version: 18.1Level: LLTClassification code 10071097Term: Beta-lactam antibiotic resistanceSystem Organ Class: 100000004862
MedDRA version: 18.1Level: LLTClassification code 10069718Term: Bacterial colonizationSystem Organ Class: 100000004862
MedDRA version: 18.1Level: LLTClassification code 10028152Term: Multi-antibiotic resistanceSystem Organ Class: 100000004862

Registration Number: EUCTR2014-003727-22-NL

Lead Sponsor: Geneva University Hospitals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 104

Inclusion Criteria

Adult patients (>= 18 years at date of inclusion)
- Documented intestinal carriage of ESBL-E and / or CRE by stool culture at baseline (visit 0)
- IF COLONIZED WITH ESBL-E ONLY (WITHOUT CRE): At least one episode of symptomatic infection
with ESBL-E requiring systemic antibiotic therapy within the last 180 days before date of inclusion
(based on the last day of antibiotic therapy for that infection)
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 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

- Pregnancy or planned pregnancy
- Breastfeeding
- Difficult / impossible follow-up
- Allergy or other contraindication to one of the study drugs
- Anatomic contraindication to the placement of a nasogastric tube
- Recurrent aspirations
- Resistance to colistin (defined as MIC> 2 mg/l) of any of the ESBL-E or CRE strains isolated at baseline
- Estimated life expectancy < 6 months
- Treatment with any systemic antibiotic on the day of inclusion
- Severe immunodeficieny
? Systemic chemotherapy =30 days from baseline or planned chemotherapy within the next 6 months
? Human Immunodeficiency Virus (HIV) with CD4 count < 250/mcl
? Prolonged use of steroids (prednisone equivalent = 60 mg per day for >= 30 days) or other immunosuppressive medications
? neutropenia with absolute neutrophil count <1000/µL,
? Solid organ transplant recipient
? Hematopoeitic stem cell transplant recepients
? Other causes of severe immunodeficiency
- Hospitalization in an Intensive Care Unit
- Estimated glomerular filtration rate (CKD-EPI) < 15 ml/min/1.73m2
- Severe food allergy (anaphylaxis, urticaria)