Status:
Ready to upload
Record number:
2065
Adverse Occurrence type:
MPHO Type:
Estimated frequency:
Use of Fecal microbiota transplants (FMT) is associated with rare inflammatory, infectious, and procedural complications.
Time to detection:
Patient 1: 17 days after the final FMT dose, patient developed a fever (38.9°C).
Patient 2: 8 days after the last FMT dose, the patient developed fever (39.7°C), chills, and altered mental status.
Alerting signals, symptoms, evidence of occurrence:
Patient 1: developed a fever (38.9°C).and chest radiography revealed an infiltrate then treated for pneumonia. The patient returned 2 days later and was admitted to the hospital. He was noted to have growth of gram-negative rods on blood cultures. After treatment using multiple antibiotic regimens, status improved.
Patient 2: developed fever (39.7°C), chills, and altered mental status then, later that evening, hypoxia and labored breathing developed, he was intubated and provided mechanical ventilation. Preliminary blood culture results indicated the presence of gram-negative rods. Despite maximum supportive measures, the patient’s condition worsened, and he died from severe sepsis 2 days later.
Demonstration of imputability or root cause:
Both cases of infection were linked to the same stool donor by means of genomic sequencing. Each of three lots of capsules from that donor was later found to contain ESBL-producing E. coli with a resistance pattern similar, but not identical, to the blood isolates from the patients, as determined by means of culture. Frozen fecal samples that were obtained from Patients 1 and 2 before FMT were cultured and found to be negative for ESBL-producing organisms. The stool donor was screened and tested appropriately according to protocols and regulations, and had no risk factors of multidrug-resistant organism carriage. Subsequently, after these serious adverse events were reported, donor-stool screening was expanded to include tests for ESBL-producing organisms using Hardy-Chrom ESBL selective agar.
Imputability grade:
3 Definite/Certain/Proven
Groups audience:
Keywords:
References:
Suggest references:
1) Drug-Resistant E. coli Bacteremia Transmitted by Fecal Microbiota Transplant. DeFilipp Z, et al. N Engl J Med. 2019 Oct 30.
2) Shogbesan O, Poudel DR, Victor S, et al. A systematic review of the efficacy and safety of fecal microbiota transplant for Clostridium difficile infection in immunocompromised patients. Can J Gastroenterol Hepatol 2018; 2018: 1394379.
3) Quera R, Espinoza R, Estay C, Rivera D. Bacteremia as an adverse event of fecal microbiota transplantation in a patient with Crohn’s disease and recurrent Clostridium difficile infection. J Crohns Colitis 2014; 8: 252-3.
Note:
Fecal microbiota transplant (FMT) could be considered as a new MPHO Type. I'm not certain whether this was discussed previously. - Done (EP)
Expert comments for publication:
These experiences warrant: 1) consideration of enhanced donor screening to limit the transmission of microorganisms that could lead to adverse infectious events and 2) continued vigilance to define the benefits and risks of FMT across different patient populations.