Intestinal Colonization With Multidrug-resistant BacteriaPhase 2R-GNOSIS WP3NCT02472600
Eradication of Antibiotic-resistant Bacteria Through Antibiotics and Fecal Bacteriotherapy
A Phase 2 study testing Colistin, Neomycin and Fecal microbiota transplantation (FMT) in people with Intestinal Colonization With Multidrug-resistant Bacteria, run by Stephen Harbarth at 4 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Colonization With Multidrug-resistant Bacteria
- What is being tested?
- Colistin, Neomycin and Fecal microbiota transplantation (FMT)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2016to Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
France1 site
Assistance Publique-Hôpitaux de Paris, Hôpital Beaujon
Clichy, 92110
About this study
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 .
Read the detailed description
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.
- Being tested
- Colistin, Neomycin, Fecal microbiota transplantation (FMT), Omeprazole
- Keywords
- extended spectrum beta-lactamase producing enterobacteriaceae, carbapenemase producing enterobacteriaceae, multidrug resistant bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColistinDrug
Also called Polymyxin E, Diarönt® mono, A07AA10
NeomycinDrug
Also called Neomycin Sulfate X-Gen, A01AB08
Fecal microbiota transplantation (FMT)Drug
Also called Fecal bacteriotherapy, Feces transplantation
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.
OmeprazoleDrug
Also called A02BC01
Administered to inhibit gastric acid secretion before FMT administration if FMT administered via nasogastric tube approach (not used for capsule approach).
| Study group | Role | What they receive |
|---|---|---|
| colistin + neomycin followed by FMT | Active comparator | CAPSULE APPROACH:
Treatment days 1-5
* Colistin sulphate 2 million IU per os 4x/day (for 5 days)
* Neomycin sulphate 500 mg (salt) per os 4x/day (for 5 days) Treatment day 6: no treatment
Treatment days 7 and 8:
-15 capsules of capsulized Fecal microbiota transplantation (FMT) per os per day
NASOGASTRIC TUBE APPROACH:
Treatment days 1-5
* Colistin sulphate 2 million IU per os 4x/day (for 5 days)
* Neomycin sulphate 500 mg (salt) per os 4x/day (for 5 days)
Treatment day 6 and 7:
- Omeprazole 20 mg per os 1 dose on the evening of day 6 and on the morning of day 7
Treatment day 7:
- Infusion of 80 ml of a standardized stool suspension through a nasogastric tube - Fecal microbiota transplantation (FMT) Receives: Drug: Colistin; Drug: Neomycin; Drug: Fecal microbiota transplantation (FMT); Drug: Omeprazole |
| No intervention | No intervention | Control arm without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal carriage of ESBL-E / CRE
Intestinal carriage of ESBL-E / CRE (absence / presence by stool culture of any ESBL-E and / or CRE with enrichment independent of type of carriage at baseline) 35 to 48 days after randomization
Measured: 35 to 48 days after randomization
Secondary outcomes (16)
Intestinal carriage of ESBL-E / CRE
Intestinal ESBL-E or CRE carriage (detected / not detected) by stool culture during the other follow-up visits
Measured: 6 months after randomization
Occurrence of any adverse drug reaction
Measured: 6 months
Occurrence of any adverse event
Measured: 6 months
Occurrence of any serious adverse event
Measured: 6 months
Occurrence of any gastrointestinal adverse event
Measured: 6 months
Isolation of any not intrinsically colistin resistant strain of Enterobacteriaceae during follow-up (MIC> 2mg/l)
Measured: 6 months
Comparison between treatment groups of the change (relative to baseline) in the proportion of bacterial taxa and antibiotic resistance genes over time
Measured: 6 months
Comparison of the global microbiota composition and diversity between the groups with FMT from the same donor and the groups with FMT from different donors
Measured: 6 months
Assess the stability of the microbiome of donor stools after 3 months of frozen storage
Aliquots from a random sample of donations will also be taken for metagenomic analysis performed after 3 months of storage at -80°C to assess the long-term impact of freezing on the microbiome
Measured: 3 months of freezing (donor stools)
Assess the stability of the microbiome of donor stools after 6 months of frozen storage
Aliquots from a random sample of donations will also be taken for metagenomic analysis performed after 6 months of storage at -80°C to assess the long-term impact of freezing on the microbiome
Measured: 6 months of freezing (donor stools)
Assess the stability of the microbiome of donor stools after 12 months of frozen storage
Aliquots from a random sample of donations will also be taken for metagenomic analysis performed after 12 months of storage at -80°C to assess the long-term impact of freezing on the microbiome
Measured: 12 months of freezing (donor stools)
Assess the stability of the microbiome of donor stools after 18 months of frozen storage
Aliquots from a random sample of donations will also be taken for metagenomic analysis performed after 18 months of storage at -80°C to assess the long-term impact of freezing on the microbiome
Measured: 18 months of freezing (donor stools)
Assess the stability of the microbiome of donor stools after 24months of frozen storage
Aliquots from a random sample of donations will also be taken for metagenomic analysis performed after 24 months of storage at -80°C to assess the long-term impact of freezing on the microbiome
Measured: 24 months of freezing (donor stools)
ESBL-E and CRE infections per 100 patient months at risk (first infection with either)
Measured: 6 months
Use of any antibiotics active against all of the colonizing ESBL-E / CRE strains
Measured: 6 months
Use of any antibiotics active against at least one of the colonizing ESBL-E / CRE strains
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startFeb 2016
- Primary completion29 Nov 2017
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intestinal Colonization With Multidrug-resistant BacteriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen Harbarth
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor-investigator, Stephen Harbarth, University Hospital, Geneva
- Investigators
- Stephan J Harbarth, MD, MS, Principal investigator, Geneva University Hospitals and University of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472600
- Sponsor's protocol ID
- 13-266
- Other IDs
- 2014-003727-22, 2014
- Acronym
- R-GNOSIS WP3
- Status last verified
- Dec 2017
- First submitted
- 4 Jun 2015
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Huttner B, Haustein T, Uckay I, Renzi G, Stewardson A, Schaerrer D, Agostinho A, Andremont A, Schrenzel J, Pittet D, Harbarth S. Decolonization of intestinal carriage of extended-spectrum beta-lactamase-producing Enterobacteriaceae with oral colistin and neomycin: a randomized, double-blind, placebo-controlled trial. J Antimicrob Chemother. 2013 Oct;68(10):2375-82. doi: 10.1093/jac/dkt174. Epub 2013 May 29.
PubMed 23719234Youngster I, Russell GH, Pindar C, Ziv-Baran T, Sauk J, Hohmann EL. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA. 2014 Nov 5;312(17):1772-8. doi: 10.1001/jama.2014.13875.
PubMed 25322359de Lastours V, Poirel L, Huttner B, Harbarth S, Denamur E, Nordmann P. Emergence of colistin-resistant Gram-negative Enterobacterales in the gut of patients receiving oral colistin and neomycin decontamination. J Infect. 2020 May;80(5):578-606. doi: 10.1016/j.jinf.2020.01.003. Epub 2020 Jan 15. No abstract available.
PubMed 31954100Huttner BD, de Lastours V, Wassenberg M, Maharshak N, Mauris A, Galperine T, Zanichelli V, Kapel N, Bellanger A, Olearo F, Duval X, Armand-Lefevre L, Carmeli Y, Bonten M, Fantin B, Harbarth S; R-Gnosis WP3 study group. A 5-day course of oral antibiotics followed by faecal transplantation to eradicate carriage of multidrug-resistant Enterobacteriaceae: a randomized clinical trial. Clin Microbiol Infect. 2019 Jul;25(7):830-838. doi: 10.1016/j.cmi.2018.12.009. Epub 2019 Jan 4.
PubMed 30616014
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02472600
- Acronym / sponsor ID
- R-GNOSIS WP3 / 13-266
- Keywords
- extended spectrum beta-lactamase producing enterobacteriaceae, carbapenemase producing enterobacteriaceae, multidrug resistant bacteria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Stephen HarbarthUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- Feb 2016
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- Mar 2018 (estimated)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colistin + neomycin followed by FMT | Active comparator | Drug: Colistin, Drug: Neomycin, Drug: Fecal microbiota transplantation (FMT), Drug: OmeprazoleCAPSULE APPROACH: Treatment days 1-5 * Colistin sulphate 2 million IU per os 4x/day (for 5 days) * Neomycin sulphate 500 mg (salt) per os 4x/day (for 5 days) Treatment day 6: no treatment Treatment days 7 and 8: -15 capsules of capsulized Fecal microbiota transplantation (FMT) per os per day NASOGASTRIC TUBE APPROACH: Treatment days 1-5 * Colistin sulphate 2 million IU per os 4x/day (for 5 days) * Neomycin sulphate 500 mg (salt) per os 4x/day (for 5 days) Treatment day 6 and 7: - Omeprazole 20 mg per os 1 dose on the evening of day 6 and on the morning of day 7 Treatment day 7: - Infusion of 80 ml of a standardized stool suspension through a nasogastric tube - Fecal microbiota transplantation (FMT) |
| No intervention | No intervention | –Control arm without any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (21 listed)
- Pregnancy or planned pregnancy
- Breastfeeding
- Difficult / impossible follow-up
- Allergy or other contraindication to one of the study drugs
- Recurrent aspirations / chronic dysphagia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColistinAlso: Polymyxin E, Diarönt® mono, A07AA10 | Drug | colistin + neomycin followed by FMT |
| NeomycinAlso: Neomycin Sulfate X-Gen, A01AB08 | Drug | colistin + neomycin followed by FMT |
| Fecal microbiota transplantation (FMT)Also: Fecal bacteriotherapy, Feces transplantationFMT 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 | colistin + neomycin followed by FMT |
| OmeprazoleAlso: A02BC01Administered to inhibit gastric acid secretion before FMT administration if FMT administered via nasogastric tube approach (not used for capsule approach). | Drug | colistin + neomycin followed by FMT |
Primary outcome
Intestinal carriage of ESBL-E / CRE
Time frame: 35 to 48 days after randomization
Intestinal carriage of ESBL-E / CRE (absence / presence by stool culture of any ESBL-E and / or CRE with enrichment independent of type of carriage at baseline) 35 to 48 days after randomization
16 secondary outcomes
Intestinal carriage of ESBL-E / CRE
Time frame: 6 months after randomization
Occurrence of any adverse drug reaction
Time frame: 6 months
Occurrence of any adverse event
Time frame: 6 months
Occurrence of any serious adverse event
Time frame: 6 months
Occurrence of any gastrointestinal adverse event
Time frame: 6 months
Isolation of any not intrinsically colistin resistant strain of Enterobacteriaceae during follow-up (MIC> 2mg/l)
Time frame: 6 months
Comparison between treatment groups of the change (relative to baseline) in the proportion of bacterial taxa and antibiotic resistance genes over time
Time frame: 6 months
Comparison of the global microbiota composition and diversity between the groups with FMT from the same donor and the groups with FMT from different donors
Time frame: 6 months
Assess the stability of the microbiome of donor stools after 3 months of frozen storage
Time frame: 3 months of freezing (donor stools)
Assess the stability of the microbiome of donor stools after 6 months of frozen storage
Time frame: 6 months of freezing (donor stools)
Assess the stability of the microbiome of donor stools after 12 months of frozen storage
Time frame: 12 months of freezing (donor stools)
Assess the stability of the microbiome of donor stools after 18 months of frozen storage
Time frame: 18 months of freezing (donor stools)
Assess the stability of the microbiome of donor stools after 24months of frozen storage
Time frame: 24 months of freezing (donor stools)
ESBL-E and CRE infections per 100 patient months at risk (first infection with either)
Time frame: 6 months
Use of any antibiotics active against all of the colonizing ESBL-E / CRE strains
Time frame: 6 months
Use of any antibiotics active against at least one of the colonizing ESBL-E / CRE strains
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Background: PubMed 23719234Huttner B, Haustein T, Uckay I, Renzi G, Stewardson A, Schaerrer D, Agostinho A, Andremont A, Schrenzel J, Pittet D, Harbarth S. Decolonization of intestinal carriage of extended-spectrum beta-lactamase-producing Enterobacteriaceae with oral colistin and neomycin: a randomized, double-blind, placebo-controlled trial. J Antimicrob Chemother. 2013 Oct;68(10):2375-82. doi: 10.1093/jac/dkt174. Epub 2013 May 29.
- Background: PubMed 25322359Youngster I, Russell GH, Pindar C, Ziv-Baran T, Sauk J, Hohmann EL. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA. 2014 Nov 5;312(17):1772-8. doi: 10.1001/jama.2014.13875.
- Derived from this study: PubMed 31954100de Lastours V, Poirel L, Huttner B, Harbarth S, Denamur E, Nordmann P. Emergence of colistin-resistant Gram-negative Enterobacterales in the gut of patients receiving oral colistin and neomycin decontamination. J Infect. 2020 May;80(5):578-606. doi: 10.1016/j.jinf.2020.01.003. Epub 2020 Jan 15. No abstract available.
- Derived from this study: PubMed 30616014Huttner BD, de Lastours V, Wassenberg M, Maharshak N, Mauris A, Galperine T, Zanichelli V, Kapel N, Bellanger A, Olearo F, Duval X, Armand-Lefevre L, Carmeli Y, Bonten M, Fantin B, Harbarth S; R-Gnosis WP3 study group. A 5-day course of oral antibiotics followed by faecal transplantation to eradicate carriage of multidrug-resistant Enterobacteriaceae: a randomized clinical trial. Clin Microbiol Infect. 2019 Jul;25(7):830-838. doi: 10.1016/j.cmi.2018.12.009. Epub 2019 Jan 4.
- Official website of the R-GNOSIS projectLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan J Harbarth, MD, MS principal investigator
Geneva University Hospitals and University of Geneva
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colistin, Neomycin and Fecal microbiota transplantation (FMT) in people with Intestinal Colonization With Multidrug-resistant Bacteria, run by Stephen Harbarth at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Israel, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal carriage of ESBL-E / CRE (time frame: 35 to 48 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02472600, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.