Summary:
A Phase 3 Placebo Controlled, 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
Recurrent Clostridium Difficile
Men and women at least 18 years of age, with a qualifying episode of CDI as defined by:
- ≥ 3 unformed stools per day for 2 consecutive days
- A positive C. difficile stool toxin assay
- The requirement of CDI SOC antibiotic therapy (defined as 10 to 21 days of treatment with vancomycin [125 mg QID] and/or fidaxomicin [200 mg BID]
- ≥ 3 episodes of CDI within the previous 12 months, inclusive of the current episode, with documented history of ≥ 2 episodes, inclusive of the current (qualifying) episode
- The requirement that the subject can be dosed with study drug within 4 days of SOC antibiotic completion
Qualified Participants May Receive:
COMPENSATION FOR TIME
COMPENSATION FOR TRAVEL
FREE MEDICATION
MEDICAL CARE
INSURANCE NOT REQUIRED