ECOSPOR III (post-hoc analysis)
Trial question
What is the effect of an oral microbiota-based therapeutic in patients with comorbidities and other risk factors for recurrent C. difficile infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
60.0% female
40.0% male
N = 182
182 patients (109 female, 73 male)
Inclusion criteria: adult patients with recurrent C. difficile infection
Key exclusion criteria: pregnancy; toxic megacolon and/or small bowel ileus; admitted to or expected to be admitted to an ICU for medical reasons; major gastrointestinal surgery; active IBD
Interventions
N=89 VOS (4 oral capsules of VOWST oral spores once daily over 3 consecutive days)
N=93 placebo (4 oral placebo capsules once daily over 3 consecutive days)
Primary outcome
Recurrence of Clostridioides difficile infection in patients with Charlson comorbidity index score ≥ 5
20
45.7
45.7 %
34.3 %
22.9 %
11.4 %
0.0 %
VOS
Placebo
Borderline significant
decrease ▼
Borderline significant decrease in recurrence of C. difficile infection in patients with Charlson comorbidity index score ≥ 5 (20% vs. 45.7%; RR 0.44, 95% CI 0.21 to 0.93)
Secondary outcomes
Borderline significant decrease in recurrence of C. difficile infection in patients with baseline CrCl > 80 mL/min (4.7% vs. 32.6%; RR 0.14, 95% CI 0.03 to 0.59)
Borderline significant decrease in recurrence of C. difficile infection in patients with prior C. difficile infection episodes ≥ 4 (17.9% vs. 46.9%; RR 0.38, 95% CI 0.18 to 0.82)
Borderline significant decrease in recurrence of C. difficile infection in patients with acid-suppressing medication use at baseline (9.1% vs. 48.8%; RR 0.19, 95% CI 0.06 to 0.57)
Conclusion
In adult patients with recurrent C. difficile infection, VOS was superior to placebo with respect to recurrence of C. difficile infection in patients with Charlson comorbidity index score ≥ 5.
Reference
Charles S Berenson, Bret Lashner, Louis Korman et al. Prevalence of comorbid factors in patients with recurrent Clostridioides difficile infection in ECOSPOR III, a randomized trial of an oral microbiota-based therapeutic. Clin Infect Dis. 2023 Nov 30;77(11):1504-1510.
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