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NCT05780801 · ClinicalTrials.gov registry record · Phase 1
Sentinel Cohort REACT
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT05780801 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 10 participants.
The verdict
NCT05780801, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is to better understand the efficacy and safety of microbiome therapies (MT) in patients with Multidrug Resistant Organism (MDRO) colonization who are admitted to Long Term Acute Care Hospitals (LTACH). This use of MT has been studied in other small studies to treat MDRO colonization, further study of the effect of MT on the transmission of MDRO to other patients is needed. This study will test the safety of the MT for this use in LTACH patients, and how well it works to help design larger studies. Importance to the field: MDRO colonization increases the risk of subsequent infection and transmission to others, however, there are no approved therapies for decolonization or reduction of the burden of colonization with MDROs. MT like Allogeneic Microbiota in Glycerol (AMG) has been shown to have \~ 60-90% efficacy for decolonization and an acceptable safety profile but has not been studied in this population for this indication. Study population: patients admitted to long-term care facilities (e.g. LTACHs and ventilator-capable skilled nursing facilities \[vSNF\]) found to be MDRO colonized during prevalence screening activities. The MT AMG will be delivered through an already existing feeding tube or into the rectum as an enema.
Interventions
- DRUG Allogeneic Microbiota in Glycerol (10%) (AMG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-04-24 |
| Est. Completion | 2024-01-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05780801
The ClinicalTrials.gov registry entry for NCT05780801 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 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 0 conditions, and to 1 intervention - of which Allogeneic Microbiota in Glycerol (10%) (AMG) is the first listed.
NCT05780801 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05780801 about?
NCT05780801 is a clinical study titled "Sentinel Cohort REACT". The purpose of this study is to better understand the efficacy and safety of microbiome therapies (MT) in patients with Multidrug Resistant Organism (MDRO) colonization who are admitted to Long Term Acute Care Hospitals (LTACH). This use of MT has been studied in other small studies to treat MDRO co...
What is the current status of trial NCT05780801?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-04-24. Estimated completion is 2024-01-31.
What interventions are being tested in trial NCT05780801?
The interventions under investigation include: Allogeneic Microbiota in Glycerol (10%) (AMG) (DRUG).
Who is sponsoring clinical trial NCT05780801?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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