Multi-Drug Resistant OrganismPhase 1NCT05780801
Sentinel Cohort REACT
A Phase 1 study testing Allogeneic Microbiota in Glycerol (10%) (AMG) in people with Multi-Drug Resistant Organism, run by Emory University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi-Drug Resistant Organism
- What is being tested?
- Allogeneic Microbiota in Glycerol (10%) (AMG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2023to 31 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to (or have an available Legal Authorized Representative who is able to) understand and be willing to sign a written informed consent document.
- Be at least 18 years old at the time of consent.
- Be able and willing to comply with all study protocol requirements, including being willing to receive MT through a feeding tube or as a retention enema.
- Be colonized with a target MDRO (CRE, VRE, ESBL, MDR Pseudomonas, and/or C. difficile) as detected by bacterial culture of stool or peri-rectal swab.
- Be willing to discontinue antibiotics, probiotics, other microbiota restoration therapies, and proton pump inhibitors (PPIs) at least one day prior to study Day 0 up to Day 28.
- The effects of the IP on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- If the potential participant is male and is sexually active with a partner of childbearing potential, the participant agrees to practice at least one effective method of birth control for the duration of the study.
- A negative urine human chorionic gonadotropin (hCG) testing on the day of FMT for women of childbearing potential (WOCBP), to proceed with FMT.
Who cannot join
- Be pregnant, breastfeeding, lactating, or planning a pregnancy during the study duration (through 4 weeks after the last dose of the investigational product (IP)), if women of childbearing potential (WOCBP).
- Have known uncontrolled intercurrent illness(es) such as, but not limited to: Symptomatic congestive heart failure, acute coronary syndrome, or cardiac arrhythmia, untreated in-situ colorectal cancer, toxic megacolon, ileus, positive stool studies without completion of treatment course (including ova and parasites, Salmonella spp, Shigella, Campylobacter, and other enteropathogens)
- Have any other intercurrent acute illness that in the opinion of the investigator will preclude the subject from entering the study.
- Be on systemic antibiotics for any reason other than treatment of recent MDRO infection or clear anticipated need for antibiotics during the follow-up period that cannot be rescheduled (e.g. fluoroquinolone prophylaxis for percutaneous nephrostomy tube exchange). Participants must complete the planned antibiotic course by study Day -1.
- Inability to discontinue proton-pump inhibitor therapy.
- Have a compromised immune system, defined as AIDS with clusters of differentiation 4 (CD4)+ T-cell count <200 and any detectable HIV viral load, absolute neutrophil count (ANC) <1,000 neutrophils / mL on the day of enrollment, active malignancy requiring intensive induction chemotherapy, radiotherapy, or biologic treatment within 2 months of enrollment or history of hematopoietic cell transplantation, either allogeneic or autologous in the last 1 year.
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- Have a history of significant food allergy that led to anaphylaxis or hospitalization.
- Have a life expectancy of 24 weeks or less
- Have any condition that, in the opinion of the investigator, might interfere with study objectives or limit compliance with study requirements, including but not limited to: Known active intravenous drug or alcohol abuse, psychiatric illness, and/or social situation
- Participated in an investigational study that also meets one of the following criteria: has received an interventional agent (drug, device, or procedure) in the last 28 days or has enrolled in any other interventional study for MDROs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sentinel Cohort for the Response to Emerging Antimicrobial Resistance With Containment Microbiota Restoration Therapy Trial
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.
Read the 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 (e.g. peri-rectal/stool, 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.
- Conditions
- Multi-Drug Resistant Organism
- Being tested
- Allogeneic Microbiota in Glycerol (10%) (AMG)
- Keywords
- Multi-Drug Resistant Pseudomonas, Clostridioides difficile, Carbapenem-resistant Enterobacteriaceae (CRE), Vancomycin-Resistant Enterococcus (VRE), Extended Spectrum Beta-Lactamase (ESBL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Microbiota in Glycerol (10%) (AMG)Drug
Also called Stool from healthy donors in saline suspension with 10% glycerol by volume, Fecal Microbiota Transplant (FMT), Microbiome therapeutic
Participants with positive MDRO cultures will receive MT instilled via a functional feeding tube when in place or rectal enema (when a functional feeding tube is not present) with the rate adjusted to the recipient's clinical status and infusion tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Live microbiome therapeutic | Experimental | Live microbiome therapeutic prepared as Allogeneic Microbiota in Glycerol (10%) (AMG) Receives: Drug: Allogeneic Microbiota in Glycerol (10%) (AMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events by MT administration in a population with a high burden of comorbidities
Frequency of adverse events from MT administration up to 1 week.
Measured: Day 7
Severity of adverse events caused by administration for MT in a population with a high burden of comorbidities
Severity of adverse events is to be graded as mild, moderate or severe, form the time of MT administration up to 1 week.
Measured: Day 7
Frequency of adverse events by MT administration in a population with a high burden of comorbidities
All adverse events will be documented from MT administration up to day 28 + 6 months.
Measured: Day 0 up to 196 days
Severity of adverse events caused by administration for MT in a population with a high burden of comorbidities
The severity of adverse events will be documented from MT administration up to day 28 + 6 months.
Measured: Day 0 up to 196 days
Secondary outcomes (1)
MT MDRO decolonization efficacy
MT MDRO decolonization efficacy will be estimated by the proportion of MT-recipient stool cultures positive for any target MDRO
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start24 Apr 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multi-Drug Resistant OrganismStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Michael Woodworth, Emory University
- Investigators
- Michael Woodworth, MD, MSc, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780801
- Sponsor's protocol ID
- STUDY00005467
- Other IDs
- U54CK000601
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share the Cultured isolate MDRO category for study inclusion, the 7-day safety data (frequency \& severity of adverse events), MDRO culture results at 4 weeks, and all the genomic/metagenomic data analyzed in any presented or published results.
Publications
Woodworth MH, Babiker A, Prakash-Asrani R, Mehta CC, Steed DB, Ashley A, Koundakjian D, Acharya A, Grooms L, Bower CW, Suchindran DR, Trehan T, Halpin AL, Spalding Walters M, Reddy SC, Samore MH, Roghmann MC, Hayden MK, Van Riel J, Burd EM, Lohsen S, Satola SW, Fridkin SK. Microbiota Transplantation Among Patients Receiving Long-Term Care: The Sentinel REACT Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2522740. doi: 10.1001/jamanetworkopen.2025.22740.
PubMed 40705333
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Cohort for the Response to Emerging Antimicrobial Resistance With Containment Microbiota Restoration Therapy Trial
- ClinicalTrials.gov ID
- NCT05780801
- Acronym / sponsor ID
- STUDY00005467
- Conditions
- Multi-Drug Resistant Organism
- Keywords
- Multi-Drug Resistant Pseudomonas, Clostridioides difficile, Carbapenem-resistant Enterobacteriaceae (CRE), Vancomycin-Resistant Enterococcus (VRE), Extended Spectrum Beta-Lactamase (ESBL)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (e.g. peri-rectal/stool, 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Live microbiome therapeutic | Experimental | Drug: Allogeneic Microbiota in Glycerol (10%) (AMG)Live microbiome therapeutic prepared as Allogeneic Microbiota in Glycerol (10%) (AMG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be able to (or have an available Legal Authorized Representative who is able to) understand and be willing to sign a written informed consent document.
- Be at least 18 years old at the time of consent.
- Be able and willing to comply with all study protocol requirements, including being willing to receive MT through a feeding tube or as a retention enema.
- Be colonized with a target MDRO (CRE, VRE, ESBL, MDR Pseudomonas, and/or C. difficile) as detected by bacterial culture of stool or peri-rectal swab.
- Be willing to discontinue antibiotics, probiotics, other microbiota restoration therapies, and proton pump inhibitors (PPIs) at least one day prior to study Day 0 up to Day 28.
Key exclusion criteria (10 listed)
- Be pregnant, breastfeeding, lactating, or planning a pregnancy during the study duration (through 4 weeks after the last dose of the investigational product (IP)), if women of childbearing potential (WOCBP).
- Have known uncontrolled intercurrent illness(es) such as, but not limited to: Symptomatic congestive heart failure, acute coronary syndrome, or cardiac arrhythmia, untreated in-situ colorectal cancer, toxic megacolon, ileus, positive stool studies without completion of treatment course (including ova and parasites, Salmonella spp, Shigella, Campylobacter, and other enteropathogens)
- Have any other intercurrent acute illness that in the opinion of the investigator will preclude the subject from entering the study.
- Be on systemic antibiotics for any reason other than treatment of recent MDRO infection or clear anticipated need for antibiotics during the follow-up period that cannot be rescheduled (e.g. fluoroquinolone prophylaxis for percutaneous nephrostomy tube exchange). Participants must complete the planned antibiotic course by study Day -1.
- Inability to discontinue proton-pump inhibitor therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Microbiota in Glycerol (10%) (AMG)Also: Stool from healthy donors in saline suspension with 10% glycerol by volume, Fecal Microbiota Transplant (FMT), Microbiome therapeuticParticipants with positive MDRO cultures will receive MT instilled via a functional feeding tube when in place or rectal enema (when a functional feeding tube is not present) with the rate adjusted to the recipient's clinical status and infusion tolerance. | Drug | Live microbiome therapeutic |
Primary outcome
Frequency of adverse events by MT administration in a population with a high burden of comorbidities
Time frame: Day 7
Frequency of adverse events from MT administration up to 1 week.
Severity of adverse events caused by administration for MT in a population with a high burden of comorbidities
Time frame: Day 7
Severity of adverse events is to be graded as mild, moderate or severe, form the time of MT administration up to 1 week.
Frequency of adverse events by MT administration in a population with a high burden of comorbidities
Time frame: Day 0 up to 196 days
All adverse events will be documented from MT administration up to day 28 + 6 months.
Severity of adverse events caused by administration for MT in a population with a high burden of comorbidities
Time frame: Day 0 up to 196 days
The severity of adverse events will be documented from MT administration up to day 28 + 6 months.
1 secondary outcome
MT MDRO decolonization efficacy
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 40705333Woodworth MH, Babiker A, Prakash-Asrani R, Mehta CC, Steed DB, Ashley A, Koundakjian D, Acharya A, Grooms L, Bower CW, Suchindran DR, Trehan T, Halpin AL, Spalding Walters M, Reddy SC, Samore MH, Roghmann MC, Hayden MK, Van Riel J, Burd EM, Lohsen S, Satola SW, Fridkin SK. Microbiota Transplantation Among Patients Receiving Long-Term Care: The Sentinel REACT Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2522740. doi: 10.1001/jamanetworkopen.2025.22740.
- Individual participant dataSharing planned: Yes. Investigators will share the Cultured isolate MDRO category for study inclusion, the 7-day safety data (frequency \& severity of adverse events), MDRO culture results at 4 weeks, and all the genomic/metagenomic data analyzed in any presented or published results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Woodworth, MD, MSc principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic Microbiota in Glycerol (10%) (AMG) in people with Multi-Drug Resistant Organism, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events by MT administration in a population with a high burden of comorbidities (time frame: Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05780801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.