ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Adult Subjects with Recurrent Clostridioides difficile Infection (RCDI)

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

3

Condition

Clostridium Difficile-associated Diarrhea

Treatment

N/A

Clinical Study ID

TX255303
  • Ages 18-100
  • All Genders

Study Summary

ECOSPOR IV is a Phase 3, multicenter, Open Label study to evaluate the safety and tolerability of SER-109 in adult subjects with recurrent CDI.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a documented history of at least 2 episodes of CDI (including a current episode) in the last 12 months
  • If currently taking probiotics, must be willing to stop at time of consent, for the duration of the study

Study Design

Study Start date:
October 22, 2020
Estimated Completion Date:

Study Description

Approximately 195 subjects with at least two episodes of CDI (including current episode) in the previous 12 months from Screening, a positive C. difficile toxin test result on a stool sample, and who have responded to standard-of-care (SOC) antibiotic treatment will be enrolled.

All enrolled subjects will have access to our Investigational Product, SER-109.

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.

SERES-013 Cohort 2 is a 24-week study, comprised of three study periods (Screening, Treatment, and Safety Follow Up), with two clinic visits and all other visits can be telephone visits.

Connect with a study center

  • Alberta Health Services (AHS) - Foothills Medical Centre (FMC)

    Calgary, Alberta T2N 2T9
    Canada

    Active - Recruiting

  • Royal Jubilee Hospital, Vancouver Island Health Authority (Viha)

    Victoria, British Columbia V8R 1J8
    Canada

    Active - Recruiting

  • St. Joseph's Health Care London - Infectious Diseases Care Program

    London, Ontario N6A 4V2
    Canada

    Active - Recruiting

  • The Gordon and Leslie Diamond Health Care Centre

    Vancouver, Ontario V5Z 1M9
    Canada

    Active - Recruiting

  • Q & T Research Chicoutimi

    Chicoutimi, Quebec G7H 7Y8
    Canada

    Active - Recruiting

  • Clinical Research Institute of Arizona, LLC

    Surprise, Arizona 85374
    United States

    Active - Recruiting

  • East Bay Institute for Research & Education - VA Northern California Health Care System

    Mather, California 95655
    United States

    Active - Recruiting

  • Sutter Health Palo Alto Medical Foundation - Mountain View Center

    Mountain View, California 94040
    United States

    Active - Recruiting

  • California Medical Research Associates, Inc.

    Northridge, California 91324
    United States

    Active - Recruiting

  • University of California, Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Medical Associates Research Group

    San Diego, California 92123
    United States

    Active - Recruiting

  • Alta California Medical Group

    Simi Valley, California 93065
    United States

    Active - Recruiting

  • Westlake Medical Research

    Thousand Oaks, California 91360
    United States

    Active - Recruiting

  • Pointe West Infectious Diseases

    Bradenton, Florida 34209
    United States

    Active - Recruiting

  • Innovative Research Of West Florida, Inc.

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • Doral Medical Research, LLC

    Doral, Florida 33166
    United States

    Active - Recruiting

  • Trials and Clinical Research of Homestead

    Homestead, Florida 33030
    United States

    Active - Recruiting

  • Jacksonville Center for Endoscopy - Southside; Borland Groover Clinic

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • A+ Research, Inc.

    Miami, Florida 33144
    United States

    Active - Recruiting

  • Continental Clinical Research

    Miami, Florida 33144
    United States

    Active - Recruiting

  • La Salud Research Clinic

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Optimus U Corporation

    Miami, Florida 33125
    United States

    Active - Recruiting

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • HMD Research LLC

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Broward Research Center

    Pembroke Pines, Florida 33024
    United States

    Active - Recruiting

  • Pines Care Research Center, LLC

    Pembroke Pines, Florida 33026
    United States

    Active - Recruiting

  • Advanced Medical Research Center

    Port Orange, Florida 32127
    United States

    Active - Recruiting

  • Summit Clinical Research, LLC

    Athens, Georgia 30607
    United States

    Active - Recruiting

  • Emory University - Emory University Hospital (EUH)

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Infectious Disease Specialists Of Atlanta (IDSA)

    Decatur, Georgia 30033-6145
    United States

    Active - Recruiting

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Aiyan Diabetes Center

    Martinez, Georgia 30907
    United States

    Active - Recruiting

  • Infinite Clinical Trials

    Morrow, Georgia 30260
    United States

    Active - Recruiting

  • Snake River Research, PLLC

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • The University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Edward Hines Jr. VA Hospital

    Hines, Illinois 60141
    United States

    Active - Recruiting

  • Springfield Clinic - Clinical Research

    Springfield, Illinois 62703
    United States

    Active - Recruiting

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana 47714
    United States

    Active - Recruiting

  • University of Iowa Hospitals & Clinics - Roy J. and Lucille A. Carver College of Medicine

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • Anne Arundel Medical Center

    Annapolis, Maryland 21401
    United States

    Active - Recruiting

  • Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • South Shore Hospital/Director of Infectious Disease - Weymouth

    Weymouth, Massachusetts 02190
    United States

    Active - Recruiting

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan 48047
    United States

    Active - Recruiting

  • Henry Ford Health Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Ahmed Arif Medical Research Center (AA MRC LLC)

    Flint, Michigan 48504
    United States

    Active - Recruiting

  • Beaumont Hospital - Royal Oak

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • St. Louis Pain Consultants

    Chesterfield, Missouri 63017
    United States

    Active - Recruiting

  • Mercury Street Medical Group, PLLC

    Butte, Montana 59701
    United States

    Active - Recruiting

  • Atlantic Digestive Health Institute

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07754
    United States

    Active - Recruiting

  • VA Western New York Healthcare System (VAWNYHS) - Buffalo VA Medical Center

    Buffalo, New York 14215-1129
    United States

    Active - Recruiting

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina 28210
    United States

    Active - Recruiting

  • Brody School Of Medicine At ECU

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • East Carolina Gastroenterology

    Jacksonville, North Carolina 28546
    United States

    Active - Recruiting

  • Kinston Medical Specialist, P.A.

    Kinston, North Carolina 28501
    United States

    Active - Recruiting

  • Summa Health System

    Akron, Ohio 44304
    United States

    Active - Recruiting

  • Valley Medical Research

    Centerville, Ohio 45459
    United States

    Active - Recruiting

  • Consultants for Clinical Research

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Cleveland Clinic - Taussig Cancer Institute

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Guthrie Medical Group, PC

    Sayre, Pennsylvania 18840
    United States

    Active - Recruiting

  • University Gastroenterology

    Providence, Rhode Island 02905
    United States

    Active - Recruiting

  • DHAT Research Institute

    Garland, Texas 75044
    United States

    Active - Recruiting

  • Wellness Clinical Research

    McKinney, Texas 75071
    United States

    Active - Recruiting

  • Texas Digestive Disease Consultants

    Southlake, Texas 76092
    United States

    Active - Recruiting

  • Care Access Research

    Ogden, Utah 84403
    United States

    Active - Recruiting

  • Advanced Clinical Research - Gut Whisperer

    Riverton, Utah 84065
    United States

    Active - Recruiting

  • Care Access Research - Salt Lake City

    Salt Lake City, Utah 84124
    United States

    Active - Recruiting

  • Fred Hutch/Seattle Cancer Care Alliance

    Seattle, Washington 98109
    United States

    Active - Recruiting

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