In primary CDI, fecal microbiota transplantation was noninferior to vancomycin for clinical cure at 14 d without recurrence at 60 d
Although fecal microbiota transplantation is a potentially attractive treatment for primary Clostridioides difficile infection (CDI), it's unlikely to become the standard of care in the near future because of both clinical questions and logistical issues, an ACP Journal Club commentary said.
An open-label noninferiority trial in Norway randomly assigned 100 adults with an initial Clostridioides difficile infection (CDI) to fecal microbiota transplantation (FMT) without antibiotic pretreatment or to oral vancomycin, 125 mg four times daily, for 10 days. FMT was noninferior to vancomycin on the study's combined primary end point of clinical cure at day 14 (firm stools or less than three bowel movements daily) and no disease recurrence within 60 days; it also met the predefined noninferiority threshold of a 25 percentage-point lower cure rate than vancomycin. The trial was stopped early after the criterion for noninferiority was met in an interim analysis.
The results were published on June 17 by Annals of Internal Medicine. The following commentary by Henry S. Sacks, PhD, MD, was published in the ACP Journal Club section of Annals of Internal Medicine on Oct. 7.
CDI is the most common cause of health care-associated diarrhea, with about 500 000 cases in the USA each year, resulting in 30 000 deaths. Although hospital-acquired CDI has decreased over time, community-acquired CDI is increasing. Current guidelines recommend antibiotic treatment for first CDI episodes and FMT for recurrent or refractory infection. How often FMT is done each year is unclear because there is no system for collecting and reporting these data.
The trial by Juul and colleagues provides evidence for the use of FMT in first episodes of CDI. It was designed as a noninferiority trial, with plans to enroll enough patients to determine whether FMT was not 25% worse than antibiotic therapy (which is a generous margin). The trial was stopped early when it became evident that FMT was at least as good as antibiotics and possibly even better. The FMT in the trial was provided by the Norwegian stool donor bank, which currently has no equivalent in the USA or Canada.
FMT is potentially attractive as primary treatment because it requires only a single administration, reduces antibiotic use, and might be less expensive if it were as readily and widely available as it is in Norway. However, as pointed out in an excellent editorial accompanying the trial, FMT is unlikely to become the standard of care in the near future because of remaining clinical questions about timing, dosage, and route of administration, as well as logistic issues about donor screening and safety testing. Because no vaccine is currently available, prevention of both inpatient and outpatient CDI by prudent antibiotic prescribing and diligent infection control should remain a high priority for providers.