Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)

NCT ID: NCT06321536

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2026-12-31

Brief Summary

REACT is a phase two, open-label, randomized, controlled trial 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, randomized, controlled trial 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 (e.g. 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) 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. Participants will be followed with collection of data on adverse events/safety/changes in medications at Days 0, 7, 14, 21, 28, and followed up once a month for 6 months, after MT administration.

Conditions

Multi-Drug Resistant Organism Colonization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1: microbiota therapy (MT)

Group 1 will offer Microbiome therapeutic (MT) to all MDRO-positive patients (i.e., intervention condition).

Group Type: EXPERIMENTAL

Allogeneic Microbiota in Glycerol (9%) (AMG)

Intervention Type: DRUG

Participants will receive an Emory-manufactured MT product, delivered as 250mL via rectal enema or 30mL instillation via an existing functioning feeding tube with the rate adjusted to participant tolerance. Participants will receive three doses over the first seven days of the study.

Group 2: Observation

Group 2 will be assigned to observation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Allogeneic Microbiota in Glycerol (9%) (AMG)

Participants will receive an Emory-manufactured MT product, delivered as 250mL via rectal enema or 30mL instillation via an existing functioning feeding tube with the rate adjusted to participant tolerance. Participants will receive three doses over the first seven days of the study.

Intervention Type: DRUG

Other Intervention Names

Fecal Microbiota Transplant (FMT); Microbiome therapeutic (MT); Stool from healthy donors in saline suspension with 9% glycerol by volume

Eligibility Criteria

Inclusion Criteria

1. Be able (or have available a Legal Authorized Representative who is able) to understand and sign a written informed consent document.

2. Be at least 18 years old at the time of consent.

3. Be able to comply with all study protocol requirements, including able to receive MT as retention enema or via enteral feeding tube and be available for the duration of the study follow up.

4. Be colonized with a target MDRO (CRE, VRE, ESBL, MDR Pseudomonas) as detected by bacterial culture of stool or peri-rectal swab (collected in companion APPS facility prevalence sampling protocol).

5. Be able to discontinue or complete planned courses of antibiotics, probiotics, and other microbiota restoration therapies by Day -1 and not resume until after Day 28.

6. The effects of the MT on the developing human fetus are unknown. For this reason, persons of child-bearing potential (POCBP) 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.

7. Agree to refrain from receptive anal intercourse until the last biological specimen (stool sample or peri-rectal swab) is collected (Day 28).

Exclusion Criteria

1. Are pregnant, breastfeeding, lactating, or planning a pregnancy during study duration (through 4 weeks after the last dose of investigational product, or MT), if POCBP.

2. Have known uncontrolled intercurrent illness(es):

1. Symptomatic congestive heart failure

2. Acute coronary syndrome

3. Cardiac arrhythmia

4. Untreated in-situ colorectal cancer

5. Toxic megacolon

6. Ileus

7. Positive stool studies without completion of treatment course (including ova and parasites, Salmonella spp, Shigella, Campylobacter, and other enteropathogens).

8. other acute illness that in the opinion of the investigator could affect the safety of the participant or make study data uninterpretable.

3. Are 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, prolonged antibiotic course for endocarditis). Participants must complete the planned antibiotic course by study Day -1.

4. Have a compromised immune system, defined as:

1. AIDS with CD4+ T-cell count <200 and detectable HIV viral load on most recent assay.

2. Absolute neutrophil count (ANC) <1,000 neutrophils / mL on day of enrollment.

3. Active malignancy requiring intensive induction chemotherapy, radiotherapy, or biologic treatment within 2 months prior to enrollment.

4. History of hematopoietic cell transplantation, either allogeneic or autologous in the last 1 year.

5. Have a history of significant food allergy that led to anaphylaxis or hospitalization.

6. Have a life expectancy of 24 weeks or less

7. 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:

1. Known active intravenous drug or alcohol abuse

2. Uncontrolled psychiatric illness

3. Social situations (e.g. incarceration)

8. Received an interventional agent (drug, device, or procedure) within 28 days prior to enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Michael Woodworth

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Woodworth, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

A.G Rhodes Wesley Woods

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory Long Term Acute Care (LTAC)

Decatur, Georgia, United States

Site Status: RECRUITING

RML Specialty Hospital

Hinsdale, Illinois, United States

Site Status: RECRUITING

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Deepti Suchindran, PhD

Role: CONTACT

deepti.rao.suchindran@emory.edu

404-727-9193

Michael Woodworth, MD

Role: CONTACT

michael.holmes.woodworth@emory.edu

Facility Contacts

Michael Woodworth, MD

Role: primary

Michael.holmes.woodworth@emory.edu

404-234-8452

Michael Woodworth, MD

Role: primary

Michael.holmes.woodworth@emory.edu

404-234-8452

Rachel Madernach, MD

Role: primary

rachel_l_medernach@rush.edu

312-947-2426

Brendan Kelly, MD

Role: primary

brendank@pennmedicine.upenn.edu

215-316-5151

Other Identifiers

U54CK000601

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007230

Identifier Type: -

Identifier Source: org_study_id