Prevalence of comorbid factors in patients with recurrent Clostridioides difficile infection in ECOSPOR III, a randomized trial of an oral microbiota-based therapeutic.

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Clinical infectious diseases : an official publication of the Infectious Diseases Society of America


BACKGROUND: Although comorbidities are risk factors for recurrent Clostridioides difficile infection (rCDI), many clinical trials exclude patients with medical conditions such as malignancy or immunosuppression. In a Phase 3, double-blind, placebo-controlled, randomized trial (ECOSPOR III), fecal microbiota spores, live (VOWSTTM; VOS, formerly SER-109), an oral microbiota therapeutic, significantly reduced the risk of rCDI at week 8. We evaluated the efficacy of VOS compared with placebo in patients with comorbidities and other risk factors for rCDI.

METHODS: Adults with rCDI were randomized to receive VOS or placebo (4 capsules daily for 3 days) following standard-of-care antibiotics. In this post-hoc analysis, the rate of rCDI through week 8 was assessed in VOS-treated subjects compared with placebo for subgroups including: a) Charlson comorbidity index (CCI) score category (0, 1-2, 3-4, ≥5); b) baseline creatinine clearance (/min, ≥30 to ≤50 ml/min, >50 ml/min to ≤80 ml/min, >80 ml/min); c) number of CDI episodes, inclusive of the qualifying episode (3 and ≥4); d) exposure to non-CDI targeted antibiotics after dosing and e) acid-suppressing medication use at baseline.

RESULTS: Of 281 subjects screened, 182 were randomized (59.9% female; mean age 65.5 years). Comorbidities were common with a mean overall baseline age-adjusted CCI score of 4.1 (4.1 in the SER-109 arm and 4.2 in the placebo arm). Across all subgroups analyzed, VOS-treated subjects had a lower relative risk of recurrence compared with placebo.

CONCLUSIONS: In this post-hoc analysis, VOS reduced the risk of rCDI compared with placebo, regardless of baseline characteristics, concomitant medications or comorbidities.

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