ECOSPOR Ill is a Phase 3, multicenter, randomized, double-blind, placebo- controlled, parallel-group study of the safety, tolerability, and efficacy of SER-109 versus placebo in adult subjects 18 years of age or older with recurrent CDI, defined as: a history of;:: 3 CDI episodes within 12 months, inclusive of the current episode. This study is designed to demonstrate the superiority of SER-109 versus placebo to reduce recurrence of Clostridium difficile infection (CDI) in adults who have received antibacterial drug treatment for recurrent CDI (RCDI), based on the proportion of subjects experiencing a CDI recurrence requiring antibiotic treatment up to 8 weeks after initiation of treatment.
Inclusion Criteria
- Positive c. difficile stool toxin assay
- 3 or more unformed stools per day for 2 consecutive days
- 3 or more episodes of CDI within the past 12 months
Exclusion Criteria
- Females who are pregnant or breastfeeding
- Suspected toxic megacolon
- History of inflammatory bowel disease causing diarrhea
Study Requirements
A total of ~27 weeks, including a ~3-week Screening Period, and 8-week Efficacy Period, and a 16-week Follow-Up Period. Up to 5 blood draw visits, stool collection.
