Last updated on February 2018

SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence

Brief description of study

The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).

Detailed Study Description

SER-262-001 is a Phase 1b, randomized, double blind, placebo-controlled, ascending single dose clinical study with 2 treatment arms (SER-262 or placebo) in up to 5 dose cohorts. Patients who have been diagnosed with their first (primary) episode of CDI, defined as diarrhea ( 3 unformed stools per day for 2 consecutive days), a positive C. difficile stool test and who have responded to standardofcare antibiotic will receive investigational drug or placebo on Day 1.

Clinical Study Identifier: NCT02830542

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Robert Brennan, MD

Infectious Disease Associates of Central Virginia
Lynchburg, VA United States
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