Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
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 col
| Condition(s) | Multi-Drug Resistant Organism Colonization |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Emory University |
| Locations | Atlanta, Georgia, United States; Decatur, Georgia, United States; Hinsdale, Illinois, United States; Philadelphia, Pennsylvania, United States |
| Start date | 2025-01-13 |
| NCT ID | NCT06321536 |
| Official listing | https://clinicaltrials.gov/study/NCT06321536 |