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)
|Beth Israel Deaconess Med Cntr - Boston, Massachusetts||2.4 miles||None||None||None|
|Massachusetts General Hospital - Boston, Massachusetts||2.8 miles||None||None||None|
|Brown Alpert Medical School - Providence, Rhode Island||40.7 miles||None||None||None|
|Parker Jewish Institute - New Hyde Park, New York||174.3 miles||None||None||None|
|Mount Sinai Hospital - New York, New York||183.2 miles||None||None||None|
|New York Presbyterian Hospital Weill Cor - New York, New York||184.8 miles||None||None||None|
|ID Care - Hillsborough, New Jersey||224.9 miles||None||None||None|
|Drexel UniversityHahnemann University Hospital - Philadelphia, Pennsylvania||269.5 miles||Daryl Spruill||Noneemail@example.com|
|Drexel UniversityHahnemann University Hospital - Philadelphia, Pennsylvania||269.5 miles||None||None||None|
|Donald Guthrie Foundation for Education - Sayre, Pennsylvania||279.7 miles||None||None||None|
|University of Rochester Medical Center - Rochester, New York||335.8 miles||None||None||None|
|Anne Arundel Health System Research Institute - Annapolis, Maryland||366.9 miles||None||None||None|
|Anne Arundel Health System Research Institute - Annapolis, Maryland||366.9 miles||kathy Gray||Nonefirstname.lastname@example.org|
|Metroploitan Gastronomy Group Pc - Chevy Chase, Maryland||391.7 miles||None||None||None|
|Metropolitan Gastronomy Group Pc - Chevy Chase, Maryland||391.7 miles||Kathy Tracey||None||Kathy.email@example.com|
|Medical Associates Of Central Virginia - Lynchburg, Virginia||549.4 miles||None||None||None|
|William Beaumont Hospital - Royal Oak, Michigan||616.2 miles||None||None||None|
|Detroit Clinical Research Center - Farmington Hills, Michigan||625.6 miles||None||None||None|
|RemingtonDavis Inc - Columbus, Ohio||641.8 miles||None||None||None|
|RemingtonDavis Inc - Columbus, Ohio||641.8 miles||Jennifer Botte||Nonefirstname.lastname@example.org|
|PMG Research of Winston Salem - Winston-Salem, North Carolina||659.2 miles||None||None||None|
|Regional Infectious DiseasesInfusion Center Inc - Lima, Ohio||680.5 miles||None||None||None|
|Regional Infectious DiseasesInfusion Center Inc - Lima, Ohio||680.5 miles||Bhuvan Doneepudi||Noneemail@example.com|
|University of Cincinnati College of Medicine - Cincinnati, Ohio||737.6 miles||None||None||None|
|University of Chicago - Chicago, Illinois||848.0 miles||None||None||None|
|Loyola University Medical Center - Maywood, Illinois||859.6 miles||None||None||None|
|Emory University - Atlanta, Georgia||932.0 miles||None||None||None|
|Sundance Clinical Research - St. Louis, Missouri||1,048.4 miles||Kelly Moushey||Nonefirstname.lastname@example.org|
|Sundance Clinical Research - St. Louis, Missouri||1,048.4 miles||None||None||None|
|University of Alabama Birmingham - Birmingham, Alabama||1,051.7 miles||None||None||None|
|Advanced Medical Research Center - Port Orange, Florida||1,071.4 miles||None||None||None|
|Advanced Medical Research Center - Port Orange, Florida||1,071.4 miles||Nicole Davis||Noneemail@example.com|
|Mayo Clinic - Chatfield, Minnesota||1,083.1 miles||None||None||None|
|Omega Research Consultants LLC - DeBary, Florida||1,094.5 miles||None||None||None|
|Center for Advanced Gastroenterology - Maitland, Florida||1,111.7 miles||None||None||None|
|Infectious Diseases Minneapolis Ltd - Minneapolis, Minnesota||1,125.1 miles||None||None||None|
|ZASA Clinical Research - Atlantis, Florida||1,206.1 miles||None||None||None|
|ZASA Clinical Research - Atlantis, Florida||1,206.1 miles||Brurva Pierre||None||BPierre@atlanticclinicalresearch.com|
|BorlandGroover Clinic - Jacksonville, Florida||1,270.5 miles||None||None||None|
|Gastroenterology Group of Naples - Napels, Florida||1,277.5 miles||None||None||None|
|Ochsner Clinic Foundation - New Orleans, Louisiana||1,363.3 miles||Susan Muery||Nonefirstname.lastname@example.org|
|Ochsner Clinic Foundation - New Orleans, Louisiana||1,363.3 miles||None||None||None|
|University of Texas School of Public Health - Houston, Texas||1,609.9 miles||None||None||None|
|Mercury Street Medical Group - Butte, Montana||2,049.8 miles||None||None||None|
|Mercury Street Medical Group - Butte, Montana||2,049.8 miles||Denise Vieke||Noneemail@example.com|
|Idaho Falls Infectious Diseases - Idaho Falls, Idaho||2,055.7 miles||None||None||None|
|North County Gastroenterology - Oceanside, California||2,573.3 miles||None||None||None|
|Northern California Clinical Research Center - Redding, California||2,626.0 miles||None||None||None|
|University Of California Davis - Sacramento, California||2,628.4 miles||None||None||None|
|Ventura Clincal Trials - Ventura, California||2,638.1 miles||Illiana Rojas||Nonefirstname.lastname@example.org|
|Ventura Clincal Trials - Ventura, California||2,638.1 miles||None||None||None|