MedTrace Logo

Eradication of Antibiotic-resistant Bacteria Through Antibiotics and Fecal Bacteriotherapy

NCT02472600 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-12-07

No results posted yet for this study

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 .

Conditions

  • Intestinal Colonization With Multidrug-resistant Bacteria

Interventions

DRUG

Colistin

DRUG

Neomycin

DRUG

Fecal microbiota transplantation (FMT)

FMT consist in the administration of fecal material obtained from healthy donors that has been diluted, homogenized, filtered and reconcentrated. In this study the processed fecal material will be frozen at -80°C after processing and will be administered to patients for up to six months after freezing via a nasogastric tube or via capsules.

DRUG

Omeprazole

Administered to inhibit gastric acid secretion before FMT administration if FMT administered via nasogastric tube approach (not used for capsule approach).

Sponsors & Collaborators

Principal Investigators

  • Stephan J Harbarth, MD, MS · Geneva University Hospitals and University of Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-11-29
Completion
2018-03-31

Countries

  • France
  • Israel
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02472600 on ClinicalTrials.gov