Sentinel Cohort REACT

Summary

The purpose of this study is to better understand the efficacy and safety of microbiome therapies (MT) in patients with Multidrug Resistant Organism (MDRO) colonization who are admitted to Long Term Acute Care Hospitals (LTACH). This use of MT has been studied in other small studies to treat MDRO colonization, further study of the effect of MT on the transmission of MDRO to other patients is needed. This study will test the safety of the MT for this use in LTACH patients, and how well it works to help design larger studies. Importance to the field: MDRO colonization increases the risk of subsequent infection and transmission to others, however, there are no approved therapies for decolonization or reduction of the burden of colonization with MDROs. MT like Allogeneic Microbiota in Glycerol (AMG) has been shown to have \~ 60-90% efficacy for decolonization and an acceptable safety profile but has not been studied in this population for this indication. Study population: patients admitted to long-term care facilities (e.g. LTACHs and ventilator-capable skilled nursing facilities \[vSNF\]) found to be MDRO colonized during prevalence screening activities. The MT AMG will be delivered through an already existing feeding tube or into the rectum as an enema.

Timeline

Start

2023-04-24

Primary completion

2024-01-31

Completion

2024-01-31

Publications

• Woodworth MH, Babiker A, Prakash-Asrani R, Mehta CC, Steed DB, Ashley A, Koundakjian D, Acharya A, Grooms L, Bower CW, Suchindran DR, Trehan T, Halpin AL, Spalding Walters M, Reddy SC, Samore MH, Roghmann MC, Hayden MK, Van Riel J, Burd EM, Lohsen S, Satola SW, Fridkin SK. Microbiota Transplantation Among Patients Receiving Long-Term Care: The Sentinel REACT Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2522740. doi: 10.1001/jamanetworkopen.2025.22740.

Drugs

Indications

No indication recorded.