Expanded Access and Open Label Extension Study of SER-109 to Prevent Recurrent Clostridium Difficile Infection

Description

SERES-005 is an open-label study for patients who have a recurrence of clostridium difficile infection in the first 8 weeks of participation in the SERES-004 study.

Study Start Date

May 2015

Estimated Completion Date

October 2016

Interventions

  • Drug: SER-109

Specialties

  • Internal Medicine: Gastroenterology,Infectious Disease
  • Infectious Disease: GI Infectious Disease,Other Viral/Bacterial
  • Gastroenterology: GI Infectious Disease

MeSH Terms

  • Clostridium difficile

Study ID

Seres Health Inc -- SERES-005

Status

Available

Trial ID

NCT02437500

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

29

Sponsor

Seres Health Inc

Inclusion Criteria

    1. Previously enrolled in Study SERES 004 and had CDI recurrence within 8 weeks after receipt of study drug. 2. Signed informed consent, indicating that the patient understands the purpose of and procedures required for the study. Patients who are unable to provide informed consent will not be included in the study. 3. The antibiotic regimen for the most recent CDI episode should comprise 14 days of oral vancomycin (125 mg, q6h) or 10 days of oral fidaxomicin (200 mg, q12h) with adequate clinical response before treatment with SER 109.

Exclusion Criteria

    1. Female patients who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study. 2. Known or suspected toxic megacolon and/or known small bowel ileus. 3. Active irritable bowel syndrome with diarrhea within the previous 24 months. 4. Major GI surgery (eg, significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy) or any history of total colectomy or bariatric surgery. 5. History of inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 24 months. 6. History of untreated celiac disease or gluten enteropathy. 7. Patients with an absolute neutrophil count < 500 cells/mm3.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (51)

Study Location Distance Name Phone Email
Parker Jewish Institute - New Hyde Park, New York 39.6 miles None None None
Mount Sinai Hospital - New York, New York 46.8 miles None None None
New York Presbyterian Hospital Weill Cor - New York, New York 48.5 miles None None None
ID Care - Hillsborough, New Jersey 88.5 miles None None None
Brown Alpert Medical School - Providence, Rhode Island 103.3 miles None None None
Drexel UniversityHahnemann University Hospital - Philadelphia, Pennsylvania 133.3 miles Daryl Spruill None dfs25@drexel.edu
Drexel UniversityHahnemann University Hospital - Philadelphia, Pennsylvania 133.3 miles None None None
Beth Israel Deaconess Med Cntr - Boston, Massachusetts 135.7 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 137.9 miles None None None
Donald Guthrie Foundation for Education - Sayre, Pennsylvania 177.9 miles None None None
Anne Arundel Health System Research Institute - Annapolis, Maryland 230.8 miles None None None
Anne Arundel Health System Research Institute - Annapolis, Maryland 230.8 miles kathy Gray None kgray7@aahs.org
Metroploitan Gastronomy Group Pc - Chevy Chase, Maryland 255.3 miles None None None
Metropolitan Gastronomy Group Pc - Chevy Chase, Maryland 255.3 miles Kathy Tracey None Kathy.tracey@capitaldigestivecare.com
University of Rochester Medical Center - Rochester, New York 260.4 miles None None None
Medical Associates Of Central Virginia - Lynchburg, Virginia 413.0 miles None None None
William Beaumont Hospital - Royal Oak, Michigan 519.0 miles None None None
RemingtonDavis Inc - Columbus, Ohio 520.0 miles Jennifer Botte None jbotte@remdavis.com
RemingtonDavis Inc - Columbus, Ohio 520.0 miles None None None
PMG Research of Winston Salem - Winston-Salem, North Carolina 523.2 miles None None None
Detroit Clinical Research Center - Farmington Hills, Michigan 528.2 miles None None None
Regional Infectious DiseasesInfusion Center Inc - Lima, Ohio 566.3 miles Bhuvan Doneepudi None bhuvan@nobadbugs.com
Regional Infectious DiseasesInfusion Center Inc - Lima, Ohio 566.3 miles None None None
University of Cincinnati College of Medicine - Cincinnati, Ohio 612.9 miles None None None
University of Chicago - Chicago, Illinois 744.7 miles None None None
Loyola University Medical Center - Maywood, Illinois 757.2 miles None None None
Emory University - Atlanta, Georgia 795.6 miles None None None
University of Alabama Birmingham - Birmingham, Alabama 915.7 miles None None None
Sundance Clinical Research - St. Louis, Missouri 929.1 miles Kelly Moushey None kmoushey@sundanceclinicalresearch.com
Sundance Clinical Research - St. Louis, Missouri 929.1 miles None None None
Advanced Medical Research Center - Port Orange, Florida 945.2 miles None None None
Advanced Medical Research Center - Port Orange, Florida 945.2 miles Nicole Davis None ndavis@amrcus.com
Omega Research Consultants LLC - DeBary, Florida 967.8 miles None None None
Center for Advanced Gastroenterology - Maitland, Florida 985.2 miles None None None
Mayo Clinic - Chatfield, Minnesota 997.5 miles None None None
Infectious Diseases Minneapolis Ltd - Minneapolis, Minnesota 1,046.2 miles None None None
ZASA Clinical Research - Atlantis, Florida 1,086.6 miles None None None
ZASA Clinical Research - Atlantis, Florida 1,086.6 miles Brurva Pierre None BPierre@atlanticclinicalresearch.com
BorlandGroover Clinic - Jacksonville, Florida 1,151.5 miles None None None
Gastroenterology Group of Naples - Napels, Florida 1,153.4 miles None None None
Ochsner Clinic Foundation - New Orleans, Louisiana 1,227.0 miles None None None
Ochsner Clinic Foundation - New Orleans, Louisiana 1,227.0 miles Susan Muery None smuery@ochsner.org
University of Texas School of Public Health - Houston, Texas 1,475.7 miles None None None
Idaho Falls Infectious Diseases - Idaho Falls, Idaho 1,972.8 miles None None None
Mercury Street Medical Group - Butte, Montana 1,976.9 miles None None None
Mercury Street Medical Group - Butte, Montana 1,976.9 miles Denise Vieke None denise.vieke@mercurystmed.com
North County Gastroenterology - Oceanside, California 2,464.5 miles None None None
Ventura Clincal Trials - Ventura, California 2,533.3 miles None None None
Ventura Clincal Trials - Ventura, California 2,533.3 miles Illiana Rojas None rohas.illiana@gmail.com
University Of California Davis - Sacramento, California 2,536.2 miles None None None
Northern California Clinical Research Center - Redding, California 2,540.2 miles None None None

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