Actively Recruiting
Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
Led by Emory University · Updated on 2025-11-05
60
Participants Needed
4
Research Sites
98 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
C
Centers for Disease Control and Prevention
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent or have a legal representative who can
- At least 18 years old at consent
- Able to comply with study protocol, including receiving microbiota therapy by enema or feeding tube and available for follow-up
- Colonized with a target MDRO (CRE, VRE, ESBL, MDR Pseudomonas) confirmed by stool or peri-rectal swab
- Able to discontinue or complete planned antibiotics, probiotics, or microbiota therapies by Day -1 and not resume until after Day 28
- Persons of child-bearing potential and men agree to use adequate contraception for study duration
- Agree to avoid receptive anal intercourse until last biological specimen collection (Day 28)
You will not qualify if you...
- Pregnant, breastfeeding, lactating, or planning pregnancy during study through 4 weeks after last dose if person of child-bearing potential
- Have uncontrolled illnesses such as symptomatic congestive heart failure, acute coronary syndrome, cardiac arrhythmia, untreated colorectal cancer, toxic megacolon, ileus, or untreated positive stool infections
- On systemic antibiotics for reasons other than recent MDRO infection or unavoidable need during follow-up; must complete planned antibiotics by Day -1
- Immunocompromised with AIDS (CD4+ <200 and detectable HIV), low neutrophil count (<1000/mL), active cancer treatment within 2 months, or recent hematopoietic transplant within 1 year
- History of severe food allergy causing anaphylaxis or hospitalization
- Life expectancy 24 weeks or less
- Conditions interfering with study such as active intravenous drug or alcohol abuse, uncontrolled psychiatric illness, or incarceration
- Received interventional agent (drug, device, procedure) within 28 days prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
A.G Rhodes Wesley Woods
Atlanta, Georgia, United States, 30329
Actively Recruiting
2
Emory Long Term Acute Care (LTAC)
Decatur, Georgia, United States, 30030
Actively Recruiting
3
RML Specialty Hospital
Hinsdale, Illinois, United States, 60521
Actively Recruiting
4
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, United States, 19146
Actively Recruiting
Research Team
D
Deepti Suchindran, PhD
CONTACT
M
Michael Woodworth, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here