SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)

Completed · Phase 2 · Has a placebo group

Conditions studied: Clostridium Difficile

In brief

The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.

Key facts

Study ID

NCT02437487

Run by

Seres Therapeutics, Inc.

People needed

89

Starts

2015-05-01

Expected to finish

2016-10-01

Last updated by the study team

2018-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Male or female patients ≥ 18 years.
• ≥ 3 episodes of CDI within the previous 9 months, inclusive of the current episode with documentation of ≥ 2 episodes.

You may not qualify if…

• Female patients who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
• Known or suspected toxic megacolon and/or known small bowel ileus.
• Active irritable bowel syndrome with diarrhea within the previous 12 months.
• Major gastrointestinal 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.
• 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.
• Admitted to or expected to be admitted to an acute care facility or intensive care unit for medical reasons (not just boarding). Patients discharged from an acute care facility before Day 1 or residing in nursing homes or rehabilitation facilities may be enrolled.
• Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).

Where it is running

• North County Gastroenterology — Oceanside, California, United States
• University Of California Davis — Sacramento, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• ZASA Clinical Research — Atlantis, Florida, United States
• Omega Research Consultants LLC — DeBary, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Advanced Medical Research Center — Port Orange, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Idaho Falls Infection Diseases — Idaho Falls, Idaho, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Anne Arundel Health System Research Institute — Annapolis, Maryland, United States
• Johns Hopkins Bayview Medical — Baltimore, Maryland, United States
• Metropolitan Gastroenterolgy Group Pc — Chevy Chase, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Med Cntr — Boston, Massachusetts, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Mayo Clinic — Chatfield, Minnesota, United States
• Sundance Clinical Research — St Louis, Missouri, United States
• Mercury Street Medical Group — Butte, Montana, United States
• Englewood Hospital and Medical Center — Englewood Cliffs, New Jersey, United States
• Mount Sinai Hospital — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
• Remington-Davis, Inc. — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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