SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence
- Registration Number
- NCT02830542
- Lead Sponsor
- Seres Therapeutics, Inc.
- Brief Summary
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).
- Detailed Description
SER-262-001 is a Phase 1b, randomized, double blind, placebo-controlled, ascending single dose clinical study with 2 treatment arms (SER-262 or placebo) in up to 8 dose cohorts. Patients who have been diagnosed with their first (primary) episode of CDI, defined as diarrhea (≥ 3 unformed stools per day for 2 consecutive days), a positive C. difficile stool test and who have responded to standard-of-care antibiotic will receive investigational drug or placebo on Day 1.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SER-262 SER-262 SER-262 \[Single dose: 10(4), 10(5), 10(6), 10(7) or 10(8) SCFUs; Multiple dose 10(6), 10(7), or 10(8) SCFUs\] Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Safety and tolerability of SER-262 as assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings Up to 24 weeks after treatment Relative risk of recurrence based on the proportion of subjects experiencing CDI recurrence in each SER-262 cohort compared to placebo up to 8 weeks after treatment Up to 8 weeks after treatment
- Secondary Outcome Measures
Name Time Method Time to recurrence of CDI Up to 24 weeks after treatment Relative risk of recurrence of CDI up to 4, 12, and 24 weeks after treatment Up to 4, 12, and 24 weeks after treatment
Trial Locations
- Locations (22)
Remington Davis
🇺🇸Columbus, Ohio, United States
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
Snake River Research
🇺🇸Idaho Falls, Idaho, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, 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
🇺🇸Saint Louis, Missouri, United States
Mercury St. Medical Group
🇺🇸Butte, Montana, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Regional Infectious Diseases & Infusion Center
🇺🇸Lima, Ohio, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Dr. Hansen Internal Medicine
🇺🇸Bountiful, Utah, United States
Baylor Scott & White Research Institute
🇺🇸Temple, Texas, United States
Infectious Disease Associates of Central Virginia
🇺🇸Lynchburg, Virginia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States