Faecal Microbiota Transplant Decreases Mortality in Severe and Fulminant Clostridioides difficile Infection in Critically Ill Patients

Emily N. Tixier; Elijah Verheyen; Ryan C. Ungaro; Ari M. Grinspan

Disclosures

Aliment Pharmacol Ther. 2019;50(10):1094-1099. 

In This Article

Results

Four hundred and twenty-six patients who had severe or fulminant CDI and required intensive care were identified between December 2013 and August 2018. Of these patients, 16 (3.8%) received FMT in addition to antibiotics. These patients were matched 1:2 with 32 controls who received SOC antibiotics alone. The average age was 62.9 years (range 19–90, SD 20.1). The average CCI score was 7.4 (range 0–14, SD 3.5). The mean number of FMTs administered was 1.4 (range 1–3). Overall, 68.8% of patients had fulminant CDI and 32.2% had severe CDI. The FMT and SOC groups were similar with the exception of mean WBC count at time of diagnosis, which was 24.6 versus 13.2 in FMT vs SOC respectively (P = .04) (Table 1). There was no significant difference between the FMT and SOC groups with respect to year in which they were admitted, pressor requirement, intubation and CCI score. There was no significant difference with regards to antibiotics used in each group. The average time from CDI diagnosis to FMT was 9.6 days (range 1–50 days, SD 9.3 days). The FMT group had a higher rate of predicted CDI-related mortality compared to the SOC group with mean CARDS score of 10.9 versus 9.3 respectively (P = .03).

Of 48 patients, 19 died during hospital admission, leading to an overall mortality rate of 39.6%. Only 3 out of 16 patients (18.8%) in the FMT group died during hospital admission compared to 16 out of 32 patients (50%) in the SOC group (P = .045). There was a 31.2% absolute risk reduction in mortality for patients undergoing FMT corresponding to a number needed to treat of 3.2 to prevent one death. In multivariable regression analysis, which adjusted for age and CCI score, FMT was still associated with a significant mortality benefit (adjusted OR 0.23, 95% CI 0.05–0.97, P = .045). Of the 48 patients, 5 underwent colectomy (10.4%). There were no differences in secondary outcomes between the groups, including colectomy rate (univariable OR 0.76, 95% CI 0.11–5.08, P = .77), repeat CDI (univariable OR 1.30, 95% CI 0.22–7.87, P = .78) and readmission (univariable OR 0.37, 95% CI 0.07–1.98, P = .24) (Table 2) Supplemental Table 1.

Sensitivity analyses to investigate the impact of FMT in fulminant cases alone yielded similar results, although they did not reach statistical significance. Of the 33 patients with fulminant CDI, 15 died during hospital admission (45.5%); 3 of 11 (27.3%) in the FMT group and 12 out of 22 (54.4%) in the SOC group (univariable OR = 0.31, 95% CI 0.07–1.50, P = .15). There were no differences in secondary outcomes within this fulminant subset. Of the 13 patients who received FMT and were discharged from the hospital, 3 (23.1%) were lost to follow-up. Of the remaining 10 FMT patients, none died within 30 days and 2 (20.0%) died within 90 days of hospital discharge. Of the 16 patients who received SOC treatment and were discharged from the hospital, 3 (18.8%) were lost to follow-up. Of the remaining 13 SOC patients, none died within 30 days and 1 (7.7%) died within 90 days of hospital discharge.

Only 4 of the 32 patients in the SOC group were evaluated for FMT. Of these four patients, two were found to be clinically improving, one had bacteraemia that precluded FMT and one acutely decompensated requiring emergent colectomy.

Of the patients who underwent FMT, 2 out of 16 (12.5%) experienced serious adverse events. One patient developed Klebsiella bacteraemia shortly after FMT that was successfully treated with a course of antibiotics and was ultimately discharged home. One patient developed a bowel perforation after FMT requiring colectomy, and died during the hospital admission. Of the patients in the SOC group, 12 of 32 (37.5%) patients developed bacteraemia and 2 of 32 patients (6.3%) developed a bowel perforation.

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