Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05780801
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2023-02-28
Brief Title:
Sentinel Cohort REACT
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Sentinel Cohort for the Response to Emerging Antimicrobial Resistance With Containment Microbiota Restoration Therapy Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg 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
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 eg 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
Detailed Description:
This protocol describes an open-label sentinel cohort study of MT treatment of 10-20 participants who are admitted to an LTACH or vSNF and colonized by a target MDRO as detected by peri-rectal or stool culture Safety data from this sentinel cohort were requested by the FDA in advance of a larger multi-center study called REACT This study is conducted in two parts In part 1 under a linked IRB protocol facilities undergo periodic point prevalence sampling for the qualitative detection of patient MDRO colonization with culture-based assays In part 2 the present protocol all MDRO-positive patients at a participating facility will be offered MT for MDRO decolonization with safety and efficacy follow-up
Bacterial isolates will be subjected to whole-genome sequencing Swabs eg peri-rectalstool inguinal will be stored for metagenomic sequencing Sequencing data are required to be shared in public repositories but sequencing reads that map to reference human genomes are removed which should greatly reduce the risk of potential identifiability of human genetic content in these datasets
Bacterial isolates will be subjected to whole-genome sequencing Swabs eg peri-rectalstool inguinal will be stored for metagenomic sequencing Sequencing data are required to be shared in public repositories but sequencing reads that map to reference human genomes are removed which should greatly reduce the risk of potential identifiability of human genetic content in these datasets
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54CK000601 | NIH | None | httpsreporternihgovquickSearchU54CK000601 |