Expanded Access and Open Label Extension Study of SER-109 to Prevent Recurrent Clostridium Difficile Infection
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
Estimated Completion Date
- Drug: SER-109
- Internal Medicine: Gastroenterology,Infectious Disease
- Infectious Disease: GI Infectious Disease,Other Viral/Bacterial
- Gastroenterology: GI Infectious Disease
- Clostridium difficile
Seres Health Inc -- SERES-005
Seres Health Inc
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.
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.
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (51)
|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||Noneemail@example.com|
|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||Nonefirstname.lastname@example.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.email@example.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||Nonefirstname.lastname@example.org|
|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||Noneemail@example.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||Nonefirstname.lastname@example.org|
|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||Noneemail@example.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||Nonefirstname.lastname@example.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||Noneemail@example.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||Nonefirstname.lastname@example.org|
|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|