Eradication of Antibiotic-resistant Bacteria Through Antibiotics and Fecal Bacteriotherapy (NCT02472600) | Clinical Trial Compass
UnknownPhase 2
Eradication of Antibiotic-resistant Bacteria Through Antibiotics and Fecal Bacteriotherapy
France, Israel, Netherlands39 participantsStarted 2016-02
Plain-language 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 .
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.