Intestinal Colonization With Multidrug-resistant Bacteria Clinical Trial
Official title:
A Randomized Controlled Multicenter Trial of a Five Day Course of Oral Colistin and Neomycin Followed by Restoration of the Gut Microbiota Using Fecal Transplantation to Eradicate Intestinal Carriage of Extended Spectrum Beta-lactamase or Carbapenemase-producing Enterobacteriaceae in High-risk Patients
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 .
In recent years a certain family of bacteria (Enterobacteriaceae) that colonizes the human
gastrointestinal tract but can also cause severe infections has increasingly become resistant
to antibiotics by acquiring enzymes that can inactivate a wide array of these valuable drugs.
Depending on the class of beta-lactam antibiotics that these enzymes can inactivate, these
bacteria are either designated as extended spectrum beta-lactamase producing
Enterobacteriaceae (ESBL-E) or carbapenemase producing Enterobacteriaceae (CPE).
The R-GNOSIS project which is financed by the European Commission combines five separate
international clinical studies (work packages 2 to 6) that examine intervention strategies to
reduce carriage, infection and spread of these bacteria. This study (work package 3 of
R-GNOSIS) will be conducted in 4 centers in 3 European countries (Switzerland, France, The
Netherlands) and Israel. The study will examine whether it is possible to eradicate
intestinal carriage with ESBL-E and CPE by administering a 5 day course of oral nonabsorbable
antibiotics (colistin sulfate and neomycin sulfate) followed by administration of "healthy"
stool flora obtained from a healthy volunteer donor ("fecal microbiota transplantation" or
FMT). The "healthy" stool flora for this procedure will be obtained from carefully selected
healthy volunteers that have been tested for a wide variety of infectious diseases and do not
show any risk factors or risky behavior for transmittable diseases. Once the fecal material
has been processed it will be frozen at -80°C for up to six months until administration to
patients (via capsules or via a nasogastric tube). FMT has been successfully used to treat
recurrent infections with a specific pathogen (Clostridium difficile) and has proven safe and
effective for this indication but has never been studied with the aim of eradicating
multidrug-resistant organisms.
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