Ecospor III: A Phase 3 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)
Principal Investigator(s)
Email for information
Funded by
Geneva
Research Start Date
Status
Active
This 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 9 months, inclusive of the current episode 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.
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