SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence

Completed · Phase 1 · Has a placebo group

Conditions studied: Clostridium Difficile Infection

In brief

The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).

Key facts

Study ID

NCT02830542

Run by

Seres Therapeutics, Inc.

People needed

96

Starts

2016-08-01

Expected to finish

2018-08-01

Last updated by the study team

2023-02-06

Who can join

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

You may qualify if…

• Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study.
• Male or female subjects ≥ 18 years.
• A primary (first) episode of CDI with documentation of the episode including CDI date, test results, antibiotic treatment (including start and stop dates), and response to treatment

You may not qualify if…

• Females 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 12 months.
• Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2
• Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Patients discharged from an intensive care unit before Day 1 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).
• Absolute neutrophil count < 500 cells/mm3

Where it is running

• North Alabama Research Center, LLC — Athens, Alabama, United States
• Lalla-Reddy Medical Corporation — Fountain Valley, California, United States
• eStudySite — La Mesa, California, United States
• San Marcus Research Clinic, Inc. — Miami, Florida, United States
• Omega Research Consultants — Orlando, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Snake River Research — Idaho Falls, Idaho, United States
• Anne Arundel Health System Research Institute — Annapolis, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Sundance Clinical Research, LLC — St Louis, Missouri, United States
• Mercury St. Medical Group — Butte, Montana, United States
• Quality Clinical Research — Omaha, Nebraska, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Remington Davis — Columbus, Ohio, United States
• Regional Infectious Diseases & Infusion Center — Lima, Ohio, United States
• Baylor Scott & White Research Institute — Temple, Texas, United States
• Dr. Hansen Internal Medicine — Bountiful, Utah, United States
• Infectious Disease Associates of Central Virginia — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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