SHM Converge Scientific Abstract ePoster Gallery-Incidence of Hospitalizations in Ecospor Iii, a Phase 3, Double-Blind, Randomized Trial in Patients With Recurrent Clostridioides Difficile Infection

Incidence of Hospitalizations in Ecospor Iii, a Phase 3, Double-Blind, Randomized Trial in Patients With Recurrent Clostridioides Difficile Infection

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This poster reports exploratory hospitalization outcomes from ECOSPOR III, a phase 3, double-blind, randomized trial of SER-109, an investigational oral microbiome therapy for adults with recurrent Clostridioides difficile infection (CDI). CDI is a major cause of morbidity, mortality, and healthcare costs, with hospitalizations being the largest cost driver. The trial enrolled 182 adults with a history of recurrent CDI who had symptom resolution after antibiotic treatment and were randomized to SER-109 or placebo.<br /><br />SER-109 had already been shown to significantly reduce CDI recurrence at Week 8, the primary endpoint, with a relative risk of 0.32. In this analysis, fewer patients in the SER-109 group experienced CDI-related or all-cause hospitalizations through Week 8. CDI-related hospitalizations occurred in 1.1% vs 6.5% by Week 4 and 2.2% vs 6.5% by Week 8 for SER-109 and placebo, respectively. All-cause hospitalizations were also lower with SER-109: 3.4% vs 16.1% by Week 4 and 7.9% vs 17.2% by Week 8.<br /><br />The treatment was generally well tolerated, with adverse event rates comparable to placebo. Common adverse events included flatulence, abdominal distension, abdominal pain, fatigue, and constipation. Serious adverse events were somewhat less frequent in the SER-109 group overall, and deaths were judged unrelated to treatment.<br /><br />The authors conclude that SER-109 may reduce hospitalizations by preventing recurrent CDI, suggesting a potential benefit not only for patients but also for the healthcare system. These findings are exploratory, but they align closely with the reduction in CDI recurrence observed in the main trial.

Asset Subtitle

Alpesh N. Amin

Meta Tag

Author List Alpesh N. Amin, Barbara H. McGovern, Charles S. Berenson, Elaine Wang, Lisa Von Moltke, Matthew Sims, Shirley Huang, Sissi Pham, Thomas Louie

Category Research

Concept Clostridioides difficile Infection

Concept ECOSPOR III Study

Concept SER-109

Concept Recurrence

Concept Recurrent Infection

Distinguished Non-Finalist

Presenter Organization University of California, Irvine

Presenting Author Alpesh N. Amin

Track Outcomes Research

Keywords

SER-109

Clostridioides difficile infection

recurrent CDI

hospitalization outcomes

phase 3 trial

randomized double-blind study

microbiome therapy

CDI recurrence

adverse events

exploratory analysis

Clostridioides difficile Infection

ECOSPOR III Study

SER-109

Recurrence

Recurrent Infection