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New treatment option for Multi-Drug Resistant Organism Colonization
Official title Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
ClinicalTrials.gov ID: NCT06321536
What this study is testing
What is Allogeneic Microbiota in Glycerol (9%) (AMG)?
Allogeneic Microbiota in Glycerol (9%) (AMG) is an investigational medicine, given as a monthly, being studied as a potential treatment for multi-drug resistant organism colonization.
Also referred to as Fecal Microbiota Transplant (FMT), Microbiome therapeutic (MT).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be able (or have available a Legal Authorized Representative who is able) to understand and sign a written informed consent document.
- Be at least 18 years old at the time of consent.
- 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...
- Be colonized with a target MDRO (CRE, VRE, ESBL, MDR Pseudomonas) as detected by bacterial culture of stool or peri-rectal swab (collected in...
- Be able to discontinue or complete planned courses of antibiotics, probiotics, and other microbiota restoration therapies by Day -1 and not resume...
You likely can't join if
- Are pregnant, breastfeeding, lactating, or planning a pregnancy during study duration (through 4 weeks after the last dose of investigational...
- Have known uncontrolled intercurrent illness(es):
- Symptomatic congestive heart failure
- Acute coronary syndrome
- Cardiac arrhythmia
- Untreated in-situ colorectal cancer
See the full eligibility criteria
- Be able (or have available a Legal Authorized Representative who is able) to understand and sign a written informed consent document.
- Be at least 18 years old at the time of consent.
- 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.
- 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).
- 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.
- 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...
- Agree to refrain from receptive anal intercourse until the last biological specimen (stool sample or peri-rectal swab) is collected (Day 28).
- 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.
- Have known uncontrolled intercurrent illness(es):
- Symptomatic congestive heart failure
- Acute coronary syndrome
- 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).
- other acute illness that in the opinion of the investigator could affect the safety of the participant or make study data uninterpretable.
- 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...
- Have a compromised immune system, defined as:
- AIDS with CD4+ T-cell count \<200 and detectable HIV viral load on most recent assay.
- Absolute neutrophil count (ANC) \<1,000 neutrophils / mL on day of enrollment.
- Active malignancy requiring intensive induction chemotherapy, radiotherapy, or biologic treatment within 2 months prior to enrollment.
- History of hematopoietic cell transplantation, either allogeneic or autologous in the last 1 year.
- 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
- Uncontrolled psychiatric illness
- Social situations (e.g. incarceration)
- Received an treatment agent (drug, device, or procedure) within 28 days prior to enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Hinsdale, Illinois, United States
- Philadelphia, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Decatur, Georgia, United States; Hinsdale, Illinois, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.