Eradication of Antibiotic-resistant Bacteria Through Antibiotics and Fecal Bacteriotherapy

• Status: Unknown status
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This investigator initiated,international, multicenter open-label, randomized controlled trial aims to assess whether a 5 day course of oral nonabsorbable antibiotics (colistin sulfate 2 million IU per os 4x/day and neomycin sulfate 500 mg (salt) per os 4x/day ) followed by fecal microbiota transplantation (administered either via nasogastric administration or via capsules) is effective at eradicating intestinal carriage of beta-lactamase producing Enterobacteriaceae (ESBL-E) and carbapenemase producing Enterobacteriaceae (CPE). compared to no intervention (current standard of care) in adult non-immunosuppressed patients .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stephen Harbarth
• Collaborator: European Commission
• Treatments: Colistin; Neomycin; Omeprazole; Polymyxins

Criteria

Inclusion Criteria:

• Adult patients (>= 18 years at date of inclusion)

• Ability to provide informed consent

• Documented intestinal carriage of ESBL-E and / or CPE by stool culture at baseline (visit 0)

• IF COLONIZED WITH ESBL-E ONLY (WITHOUT CPE): 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)

Exclusion Criteria:

• Pregnancy or planned pregnancy

• Breastfeeding

• Difficult / impossible follow-up

• Allergy or other contraindication to one of the study drugs

• Recurrent aspirations / chronic dysphagia

• Resistance to colistin (defined as MIC> 2 mg/l) of any of the ESBL-E or CPE strains isolated at baseline

• Estimated life expectancy < 6 months

• Treatment with any systemic antibiotic on the day of inclusion

• Severe immunodeficiency

• 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

• Hematopoeitic stem cell transplant recipients

• Other causes of severe immunodeficiency

• Current hospitalization in an Intensive Care Unit

• Estimated glomerular filtration rate (CKD-EPI) < 15 ml/min/1.73m2

• Severe food allergy (anaphylaxis, urticaria)

• Unavailability of compatible FMT preparation (with regard to donor / recipient cytomegalovirus, Epstein-Barr virus and toxoplasma serology)

• Anatomic contraindication to the placement of a nasogastric tube (only if FMT application via nasogastric tube)