Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT) (NCT06321536) | Clinical Trial Compass
RecruitingPhase 2
Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
United States60 participantsStarted 2025-01-13
Plain-language 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
Age range18 Years
SexALL
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Inclusion 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; abstinence) prior to study entry and for the duration of study participation.
✓. Agree to refrain from receptive anal intercourse until the last biological specimen (stool sample or peri-rectal swab) is collected (Day 28).
Exclusion criteria
✕. 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):
What they're measuring
1
Difference in number of solicited Adverse Events (AEs)
Timeframe: Day 0, Day 7 post-intervention
2
Difference in severity of solicited AEs
Timeframe: Day 0, Day 7 post-intervention
3
Difference in number of unsolicited AEs
Timeframe: Day 0, Day 28 post-intervention
4
Difference in severity of unsolicited AEs
Timeframe: Day 0 and Day 28
5
Difference in proportion of participant stool positive cultures for any target MDRO among AMG-treated compared to Observation participants