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ECOSPOR Ill


Title ECOSPOR Ill: A Phase 2 Multicenter, RandomizeEd, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of SER-109 vs. Placebo to Reduce Recurrence of Clostridium difficile Infection (CDI) in Adults Who Have Received Antibacterial Drug Treatment for Recurrent CDI (RCDI) 
Therapeutic Area Clostridium Difficile Infection
Principal Investigator Dr. Yoav Golan
Min Age 18 Years
Gender All
Contact Deirdre Burke
617-636-3665
More Information https://www.clinicaltrials.gov/ct2/show/NCT3183128

Overview

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. 

Study Details

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.