Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy

Emory University

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.

Description

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 pa…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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…

Interventions

Drug
Allogeneic Microbiota in Glycerol (9%) (AMG)
Participants will receive an Emory-manufactured MT product, delivered as 250mL via rectal enema or 30mL instillation via an existing functioning feeding tube with the rate adjusted to participant tolerance. Participants will receive three doses over the first seven days of the study.

Locations (4)

A.G Rhodes Wesley Woods
Atlanta, Georgia
Michael.holmes.woodworth@emory.edu 404-234-8452
Emory Long Term Acute Care (LTAC)
Decatur, Georgia
Michael.holmes.woodworth@emory.edu 404-234-8452
RML Specialty Hospital
Hinsdale, Illinois
rachel_l_medernach@rush.edu 312-947-2426
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania
brendank@pennmedicine.upenn.edu 215-316-5151