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NCT05835206 · ClinicalTrials.gov registry record · Phase 2
Further MT for Antibiotic-Resistant Bacterial Colonization in Inpatients
A Phase 2 study of Multi-drug Resistant Organism, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 5
- Study locations
NCT05835206 is a Phase 2 study of Multi-drug Resistant Organism that is actively recruiting participants, run by Emory University. The registered enrollment target is 40 participants. The trial reports 5 study locations across 1 state.
The verdict
NCT05835206, a Phase 2 study of Multi-drug Resistant Organism, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to better understand the effectiveness and safety of microbiome therapies (MT) as a treatment for patients with Multidrug Resistant Organism (MDRO) colonization after an infection. Limited data from prior studies suggest that MT may be an effective treatment to reduce intestinal MDRO colonization Although shedding of MDROs from patients to their surrounding environment is a recognized pathway of transmission, the potential effect of MT on the transmission of MDRO to other patients in the hospital environment is unclear. This study will test the safety and efficacy of MT for this use in hospitalized patients. This study will also help design larger studies. The MT may help reduce MDROs that colonize the gut. By reducing colonization before infections happen, this could help doctors avoid using "last resort" antibiotics that can have serious side effects like kidney damage. The reduction in MDROs after MT was originally identified in patients treated with MT for recurrent Clostridioides difficile (often called "C. diff") diarrhea. It has been shown that a type of MT called fecal microbiota transplant (FMT) can eliminate both C. difficile and other resistant bacteria.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Microbiome Therapeutic
Study Locations (5)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory Rehabilitation Hospital - Atlanta
- Emory University Clinical Research Network - Atlanta
- Emory University Hospital (EUH) - Atlanta
- Emory University at Wesley Woods Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-04-25 |
| Est. Completion | 2026-07-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05835206
The ClinicalTrials.gov registry entry for NCT05835206 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multi-drug Resistant Organism appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05835206 reports 5 study locations spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT05835206 about?
NCT05835206 is a clinical study titled "Further MT for Antibiotic-Resistant Bacterial Colonization in Inpatients". The purpose of this study is to better understand the effectiveness and safety of microbiome therapies (MT) as a treatment for patients with Multidrug Resistant Organism (MDRO) colonization after an infection. Limited data from prior studies suggest that MT may be an effective treatment to reduce in...
What is the current status of trial NCT05835206?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-04-25. Estimated completion is 2026-07-30.
What conditions does trial NCT05835206 study?
This clinical trial studies the following conditions: Multi-drug Resistant Organism.
What interventions are being tested in trial NCT05835206?
The interventions under investigation include: Placebo (DRUG), Microbiome Therapeutic (DRUG).
Who is sponsoring clinical trial NCT05835206?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05835206 being conducted?
This trial has 5 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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