A paper yesterday in the New England Journal of Medicine is offering new details on the two patients who developed drug-resistant bloodstream infections after undergoing fecal microbiota transplantation (FMT).
The two patients, one of whom died, were first reported by the Food and Drug Administration (FDA) in a Jun 13 safety alert, in which the agency warned of the potential for dangerous infections with the use of FMT—a procedure that involves the transfer of stool from a healthy donor via capsule or colonoscopy. The agency also halted a number of FMT trials until additional screening could be put in place.
At the time of the announcement, no additional details on the patients—where they were treated, and why they were receiving FMT—were offered. But the FDA noted that the invasive infections had been caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, and that stool used in the two procedures came from the same donor.
In the paper, researchers at Massachusetts General Hospital reveal that the two patients were enrolled in FMT trials at the hospital last spring, and became ill in the weeks following their FMT procedures. Using whole-genome sequencing, the researchers—including clinicians involved in the trials—confirmed that the strain of ESBL-producing E coli that caused the infections were nearly identical to a strain isolated from the stool of a single donor.
Stool not screened for ESBL-producing bacteria
Read more at CIDRAP…