Sentinel Cohort REACT

This protocol describes an open-label sentinel cohort study of MT treatment of 10-20 participants who are admitted to an LTACH or vSNF and colonized by a target MDRO as detected by peri-rectal or stool culture. Safety data from this sentinel cohort were requested by the FDA in advance of a larger multi-center study called REACT. This study is conducted in two parts. In part 1 (under a linked IRB protocol), facilities undergo periodic point prevalence sampling for the qualitative detection of patient MDRO colonization with culture-based assays. In part 2 (the present protocol) all MDRO-positive patients at a participating facility will be offered MT for MDRO decolonization with safety and efficacy follow-up. Bacterial isolates will be subjected to whole-genome sequencing. Swabs (e.g. peri-rectal/stool, inguinal) will be stored for metagenomic sequencing. Sequencing data are required to be shared in public repositories but sequencing reads that map to reference human genomes are removed, which should greatly reduce the risk of potential identifiability of human genetic content in these datasets.