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Gastroenterology. 2019 Jan 2. pii: S0016-5085(18)35434-9. doi: 10.1053/j.gastro.2018.12.019. [Epub ahead of print]

Fecal Microbiota Transplantation is Superior to Fidaxomicin for Treatment of Recurrent Clostridium difficile Infection.

Author information

1
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark. Electronic address: christian.hvas@auh.rm.dk.
2
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
3
Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark.
4
Department of Clinical Microbiology, Aarhus University Hospital, Aarhus, Denmark.
5
Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.

Abstract

BACKGROUND & AIMS:

Fecal microbiota transplantation (FMT) is recommended for treatment of recurrent Clostridium difficile infection (rCDI). We performed a single-center, randomized trial to compare the effects of FMT with those of fidaxomicin and vancomycin.

METHODS:

We studied consecutive adults with rCDI seen at a gastroenterology clinic in Denmark, from April 5, 2016 through June 10, 2018. Patients were randomly assigned to a group that received FMT, applied by colonoscopy or nasojejunal tube after 4-10 days of vancomycin (125 mg 4 times daily; FMTv; n = 24), 10 days of fidaxomicin (200 mg twice daily; n = 24), or 10 days of vancomycin (125 mg 4 times daily; n = 16). Patients who had recurrence of CDI following this course of treatment and patients who could not be randomly assigned to groups were offered rescue FMTv. The primary outcome was combined clinical resolution and a negative result from a PCR test for Clostridium difficile (CD) toxin 8 weeks following the allocated treatment. Secondary endpoints included clinical resolution at week 8.

RESULTS:

All 64 patients received their assigned treatment. The combination of clinical resolution and negative results from the test for CD were observed in 17 patients with FMTv (71%), 8 patients given fidaxomicin (33%), and 3 patients given vancomycin (19%) (P for FMTv vs fidaxomicin = .009; P for FMTv vs vancomycin = .001; P for fidaxomicin vs vancomycin = .31). Clinical resolution was observed in 22 patients given FMTv (92%), 10 patients given fidaxomicin (42%), and 3 patients given vancomycin (19%) (P = .0002; P < .0001; P = .13). Results did not differ significantly between patients who received FMTv as their initial therapy and patients who received rescue FMTv. There was 1 serious adverse event that might have been related to FMTv.

CONCLUSIONS:

In a randomized trial of patients with rCDI, we found the combination of vancomycin and FMT to be superior to fidaxomicin or vancomycin, based on endpoints of clinical and microbiological resolution or clinical resolution alone. ClinicalTrials.gov no: NCT02743234. EudraCT j.no: 2015-003004-24.

KEYWORDS:

antibiotic; bacteria; comparison; microbiome

PMID:
30610862
DOI:
10.1053/j.gastro.2018.12.019
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