Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321536
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-13
Brief Title:
Response to Emerging Antimicrobial Resistance with Containment Microbiota Therapy REACT
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Response to Emerging Antimicrobial Resistance with Containment Microbiota Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
REACT is a phase two open-label cluster randomized crossover study of microbiota therapy MT to reduce colonization with multi-drug resistant organisms MDRO REACT is designed to assess the safety and efficacy of MT administered to subjects colonized with a MDRO The overarching hypothesis is that MT can reduce MDRO colonization with safety that is comparable to observation
Detailed Description:
REACT is a phase two open-label cluster randomized crossover study of microbiota therapy MT to reduce colonization with multi-drug resistant organisms MDRO in patients admitted to long-term care facilities REACT is designed to test the safety and efficacy of instillation of donor intestinal microbiota
Patients admitted to long-term care facilities eg long-term acute care hospitals and ventilator-capable skilled nursing facilities found to be MDRO colonized during prevalence screening activities performed in the related APPS study
Facilities undergo prevalence sampling that involves participant peri-rectal inguinal and stool sampling to estimate the prevalence of targeted MDROs CRE ESBL VRE MDRP C difficile under the accompanying APPS protocol Patients who are positive with at least one targeted MDRO are eligible for an Emory manufactured MT product via rectal enema or feeding tube or observation followed by repeat sampling at Days 7 14 21 and 28 A repeat prevalence sample will then be conducted at all facilities After a washout period facilities then undergo another prevalence sample crossover to the opposite assignment for recruiting patients ie Observation - MT or MT - Observation followed by another facility prevalence sample Participants will be followed with collection of data on adverse eventssafetychanges in medications at Days 0 7 14 21 28 and followed up once a month for 6 months after MT administration
Patients admitted to long-term care facilities eg long-term acute care hospitals and ventilator-capable skilled nursing facilities found to be MDRO colonized during prevalence screening activities performed in the related APPS study
Facilities undergo prevalence sampling that involves participant peri-rectal inguinal and stool sampling to estimate the prevalence of targeted MDROs CRE ESBL VRE MDRP C difficile under the accompanying APPS protocol Patients who are positive with at least one targeted MDRO are eligible for an Emory manufactured MT product via rectal enema or feeding tube or observation followed by repeat sampling at Days 7 14 21 and 28 A repeat prevalence sample will then be conducted at all facilities After a washout period facilities then undergo another prevalence sample crossover to the opposite assignment for recruiting patients ie Observation - MT or MT - Observation followed by another facility prevalence sample Participants will be followed with collection of data on adverse eventssafetychanges in medications at Days 0 7 14 21 28 and followed up once a month for 6 months after MT administration
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 |