At a glance
ClinicalIndex Comparison Record- ✓Cohort 1: Previously enrolled in SERES-012 with CDI recurrence within 8 weeks after SER-109 or placebo
- ✓Cohort 1: CDI recurrence meeting protocol definition (≥3 unformed stools/day for 2 consecutive days, positive C. difficile toxin, antibiotic therapy, and adequate response <3 unformed stools in 24 hours for ≥2 consecutive days)
- ✓Cohort 2: Age ≥18 years with ≥1 CDI recurrence confirmed by C. difficile stool toxin or PCR and responsive to antibiotic treatment
- ✕Pregnancy, breastfeeding, lactation, or planning pregnancy during study
- ✕Known or suspected toxic megacolon and/or small bowel ileus
- ✕ICU admission for medical reasons (nursing homes, rehabilitation, assisted living, acute care hospitals acceptable)
- ✕Absolute neutrophil count <500 cells/mm³
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Subjects With Recurrent Clostridioides Difficile Infection (RCDI)
In Brief
A Phase 3 clinical trial evaluating SER-109 for Clostridioides Difficile Infection. Completed, enrolled 263 participants across 107 sites in 2 countries.
Detailed Summary
Cohort 1: Subjects who had a Clostridioides difficile infection (CDI) recurrence in study SERES-012 within 8 weeks of receipt of study drug will be eligible. The purpose of this cohort is to assess safety and efficacy of SER-109 in reducing recurrence of CDI in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in study SERES-012. Cohort 2: Cohort 2 is an open-label program for subjects who were not part of SERES-012. The purpose of this cohort is to describe safety and tolerability of SER-109 in subjects 18 years of age or older with at least a first recurrence of CDI.
Study Details
Timeline
Interventions
SER-109, an oral, biologically derived, live microbiome therapeutic that comprises purified bacterial spores