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SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI) — ECOSPOR  

Clostridium Difficile Clinical Trial

Official title:
ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection

Clinical Trial Summary

The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.

Clinical Trial Description

ECOSPOR is a Phase 2, multicenter, randomized, double blind, placebo controlled clinical study with 2 treatment arms (SER-109 or placebo). Patients who have diarrhea and a positive C. difficile test result on a stool sample, and who have responded to standard of care antibiotic treatment will receive study drug on Day 1.

Those patients who experience a recurrence of CDI up to 8 weeks after SER 109 or placebo treatment will be offered an opportunity to enroll in an open label SER 109 extension study (Study SERES 005). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02437487
Study type Interventional
Source Seres Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date May 2015
Completion date October 2016
View Details
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