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.
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 participant peri-rectal, inguinal, and stool sampling to estimate the prevalence of targeted MDROs (CRE, ESBL, VRE, MDRP) under the accompanying APPS protocol. Patients who are positive with at least one targeted MDRO are eligible for an Emory manufactured MT product (via rectal enema or feeding tube), or observation followed by repeat sampling at Days 7, 14, 21, and 28. Participants will be followed with collection of data on adverse events/safety/changes in medications at Days 0, 7, 14, 21, 28, and followed up once a month for 6 months, after MT administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
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.
A.G Rhodes Wesley Woods
Atlanta, Georgia, United States
RECRUITINGEmory Long Term Acute Care (LTAC)
Decatur, Georgia, United States
RECRUITINGRML Specialty Hospital
Hinsdale, Illinois, United States
RECRUITINGDifference in number of solicited Adverse Events (AEs)
Difference in number of solicited AEs between Day 0 and Day 7 in AMG-treated vs Observation participants.
Time frame: Day 0, Day 7 post-intervention
Difference in severity of solicited AEs
Difference in severity of solicited AEs will be compared in AMG-treated vs Observation participants. Graded as mild, moderate or severe, up to 7 days post-intervention.
Time frame: Day 0, Day 7 post-intervention
Difference in number of unsolicited AEs
Difference in number of unsolicited AEs between Day 0 and Day 28 in AMG-treated vs Observation participants.
Time frame: Day 0, Day 28 post-intervention
Difference in severity of unsolicited AEs
Difference in severity of unsolicited AEs will be collected between Day 0 and Day 28. Graded as mild, moderate or severe and compared in AMG-treated vs Observation participants
Time frame: Day 0 and Day 28
Difference in proportion of participant stool positive cultures for any target MDRO among AMG-treated compared to Observation participants
Difference in proportion of participant stool cultures at Day 28 positive will be measured for any target MDRO among AMG-treated compared to Observation participants
Time frame: Day 28 post-intervention
Count of serious AEs (SAEs)
Count of serious AEs (SAEs) between Day 0 and Month 6 (Day 180) censored by last telephone visits or death, whichever is later.
Time frame: Day 180
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Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, United States
RECRUITINGCount of AEs of Special Interest (AESIs)
Count of AEs of Special Interest (AESIs) at day Day 180, censored by last telephone visit or death, whichever is later.
Time frame: Day 180
Proportion of stool cultures at Day 28 positive for category-specific MDROs
Proportion of stool cultures at Day 28 positive for category-specific MDROs (e.g. ESBL, CRE, MDRP, VRE).
Time frame: Day 28