Fecal-microbiota transplantation (FMT) is superior to 10 days of fidaxomicin or vancomycin for resolving recurrent Clostridium difficile infection (CDI), according to results from a randomized open-label clinical trial. The researchers report in Gastroenterology.
Patient with recurrence of C. diff. is considered for FMT
"Any patient with recurrence of C. diff. should be considered for FMT," Dr. Christian Lodberg Hvas from Aarhus University Hospital, in Denmark told Reuters Health by email. "Some think that long-term vancomycin is the better choice, particularly in the multimorbid patient. We now know that this is not true."
Numerous studies have shown FMT to be superior to vancomycin for treating recurrent CDI, but FMT has not been compared with recently developed, oral, non-absorbable antibiotics like fidaxomicin. Dr. Hvas' team compared the effects of FMT, fidaxomicin and standard-dose vancomycin in 64 patients with recurrent CDI.
Clinical resolution rates were also significantly higher
Combined clinical resolution and a negative C. difficile test, the primary outcome, were achieved by 17 (71%) FMT patients, eight (33%) fidaxomicin patients, and three (19%) vancomycin patients, with FMT statistically superior to fidaxomicin and vancomycin. Clinical resolution rates were also significantly higher with FMT (22/24, 92%) than with fidaxomicin (10/24, 42%) or vancomycin (3/16, 19%).
"Recurrent CDI may be life-threatening," Dr. Hvas said. "In patients who are ill and have recurrence, I think FMT should be considered first choice. This also applies to those in intensive care, in nursing homes, and those who are disabled by their disease. Before, we considered some patients 'too sick for FMT.' Now, we know that the sicker the patient, the stronger the argument for FMT."
Dr. Berhanu M. Geme told Reuters Health by email, "FMT is a highly effective and readily available treatment for recurrent CDI. In fact, effectiveness of FMT is better than oral vancomycin. Most of our patient start feeling better the first week after FMT."
FMT has a number of drawbacks
Dr. Horace R. D. Williams told, "Based on primary outcome alone, many would raise the question whether FMT should be the first port-of-call for all recurrent CDI (not CDI per se). However, FMT has a number of drawbacks, including its unpalatability, the potential need for invasive administration, the theoretical risk of transmission of infection, and the complex regulation associated with its use."
"Furthermore, this study only included patients with extremely stubborn recurrent CDI, who had failed vancomycin and other therapies up to seven times before in some cases – so this is a selective and extreme population," he said. "As such, this study certainly should not be seen as dismissive of the important role of pharmacotherapy in the treatment of recurrent CDI."
"It may be appropriate to consider FMT earlier in the pathway of treatment for patients with recurrent CDI than is currently the case (which is typically after a least two recurrences)," Dr. Williams said. "However, it should be recognized that vancomycin and fidaxomicin both still have an important role in the treatment of recurrent CDI."