Last updated on May 2019

ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection


Brief description of study

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CDI in adults up to 8 weeks after initiation of treatment.

Detailed Study Description

ECOSPOR III 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. 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. Approximately 188 subjects with a history of CDI, diarrhea and a positive C. difficile toxin test result on a stool sample, who have responded to standard-of-care (SOC) antibiotic treatment will be enrolled. Subjects will be randomly assigned, in a 1:1 ratio, to 1 of 2 treatment groups (Treatment Group I [SER-109] or Treatment Group II [Placebo]) and stratified by age (<65 years; 65 years), as well as antibiotic regimen for the qualifying episode (vancomycin; fidaxomicin).

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II.

Subjects with confirmed CDI recurrence, as defined in the Protocol, up to 8 weeks after administration of SER-109 or placebo treatment, and who have completed their Week 8 visit, may be eligible to enroll in the open- label SER-109 extension study (Study SERES-013).

Clinical Study Identifier: NCT03183128

Find a site near you

Start Over

Mercury Street Medical

Butte, MT United States
  Connect »

Heritage Medicine

Birmingham, AL United States
  Connect »

Arkansas Gastroenterology, PA

North Little Rock, AR United States
  Connect »

UC Davis Medical Center

Sacramento, CA United States
  Connect »

Care Access Research San Pablo

San Pablo, CA United States
  Connect »

Alta California Medical Group

Simi Valley, CA United States
  Connect »

Westlake Medical Research

Thousand Oaks, CA United States
  Connect »

Empire Clinical Research

Upland, CA United States
  Connect »

Georgetown University Hospital

Washington, WA United States
  Connect »

Empirical Research Group

Gainesville, FL United States
  Connect »

La Salud Research Clinic

Miami, FL United States
  Connect »

HMD Research LLC

Orlando, FL United States
  Connect »

Broward Research Center

Pembroke Pines, FL United States
  Connect »

Pines Care Research Center, LLC

Pembroke Pines, FL United States
  Connect »

Advanced Medical Research Center

Port Orange, FL United States
  Connect »

Asclepes Research Centers

Weeki Wachee, FL United States
  Connect »

Triple O Research Institute PA

West Palm Beach, FL United States
  Connect »

Emory University Hospital

Atlanta, GA United States
  Connect »

Doctors Clinical Research

East Point, GA United States
  Connect »

Infinite Clinical Trials

Riverdale, GA United States
  Connect »

Mt. Vernon Clinical Research

Sandy Springs, GA United States
  Connect »

Snake River Research, Pllc

Idaho Falls, ID United States
  Connect »

RxClinicals

Crystal Lake, IL United States
  Connect »

Carle Foundation Hospital

Urbana, IL United States
  Connect »

American Research, LLC

Jeffersonville, IN United States
  Connect »

Benton Oubre, MD

Baton Rouge, LA United States
  Connect »

Ochsner Clinic Foundation

New Orleans, LA United States
  Connect »

Anne Arundel Medical Center

Annapolis, MD United States
  Connect »

South Shore Hospital

Weymouth, MA United States
  Connect »

Henry Ford Health Hospital

Detroit, MI United States
  Connect »

Beaumont Hospital

Royal Oak, MI United States
  Connect »

Mayo Clinic

Rochester, MN United States
  Connect »

Sundance Clinical Research, LLC

Saint Louis, MO United States
  Connect »

AB Clinical Trials

Las Vegas, NV United States
  Connect »

Concorde Medical Group, PLLC

New York, NY United States
  Connect »

Onsite Clinical Solutions

Asheville, NC United States
  Connect »

Brody School of Medicine at ECU

Greenville, NC United States
  Connect »

East Carolina Gastroenterology

Jacksonville, NC United States
  Connect »

Carolinas GI Research

Raleigh, NC United States
  Connect »

Valley Medical Research

Centerville, OH United States
  Connect »

Remington Davis

Columbus, OH United States
  Connect »

University of Pittsburgh

Pittsburgh, PA United States
  Connect »

MD First Research

Anderson, SC United States
  Connect »

Gastroenterology Associates, PA

Greenville, SC United States
  Connect »

Office of Dr. Val R Hansen, MD

Bountiful, UT United States
  Connect »

University of Virginia Medical Center

Charlottesville, VA United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.