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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Participants with positive MDRO cultures will receive MT instilled via a functional feeding tube when in place or rectal enema (when a functional feeding tube is not present) with the rate adjusted to the recipient's clinical status and infusion tolerance.
Emory Long-Term Acute Care
Decatur, Georgia, United States
Frequency of adverse events by MT administration in a population with a high burden of comorbidities
Frequency of adverse events from MT administration up to 1 week.
Time frame: Day 7
Severity of adverse events caused by administration for MT in a population with a high burden of comorbidities
Severity of adverse events is to be graded as mild, moderate or severe, form the time of MT administration up to 1 week.
Time frame: Day 7
Frequency of adverse events by MT administration in a population with a high burden of comorbidities
All adverse events will be documented from MT administration up to day 28 + 6 months.
Time frame: Day 0 up to 196 days
Severity of adverse events caused by administration for MT in a population with a high burden of comorbidities
The severity of adverse events will be documented from MT administration up to day 28 + 6 months.
Time frame: Day 0 up to 196 days
MT MDRO decolonization efficacy
MT MDRO decolonization efficacy will be estimated by the proportion of MT-recipient stool cultures positive for any target MDRO
Time frame: Day 14
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