PEACH-REACT

Treatment for Reducing Multi-Drug Resistant Organism Colonization in Long-Term Care Facilities

Recruiting
18 years or above
All
Phase 2
60 participants needed
1 Location

Brief description of study

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 of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multi-Drug Resistant Organism Colonization
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the use of microbiota therapy for reducing colonization with multi-drug resistant organisms in patients. The condition being focused on is the presence of these resistant organisms in individuals admitted to long-term care facilities.

The study evaluates the safety and effectiveness of administering microbiota therapy to patients colonized with these resistant organisms. It is important to determine if this therapy is safe and can effectively reduce the presence of the organisms in comparison to just observing the patients.

  • Who can participate: Adults 18 years and older who are colonized with a multi-drug resistant organism are eligible. Participants must be able to comply with study requirements and have no significant uncontrolled illnesses.
  • Study details: Participants will receive microbiota treatment through a rectal enema or feeding tube. They may also be observed without treatment. A placebo is not used in this study.
Updated on 05 Nov 2025. Study ID: 25-0581

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