SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
This trial is active, not recruiting.
|Sponsor||Seres Therapeutics, Inc.|
|Start date||May 2015|
|End date||June 2016|
|Trial size||87 participants|
|Trial identifier||NCT02437487, SERES-004|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Birmingham, AL||University of Alabama - Birmingham||no longer recruiting|
|Oceanside, CA||North County Gastroenterology||no longer recruiting|
|Sacramento, CA||University Of California Davis||no longer recruiting|
|Ventura, CA||Ventura Clinical Trials||no longer recruiting|
|Atlantis, FL||ZASA Clinical Research||no longer recruiting|
|DeBary, FL||Omega Research Consultants LLC||no longer recruiting|
|Jacksonville, FL||Borland-Groover Clinic||no longer recruiting|
|Naples, FL||Gastroenterology Group of Naples||no longer recruiting|
|Port Orange, FL||Advanced Medical Research Center||no longer recruiting|
|Atlanta, GA||Emory University||no longer recruiting|
|Idaho Falls, ID||Idaho Falls Infection Diseases||no longer recruiting|
|Chicago, IL||University of Chicago||no longer recruiting|
|Maywood, IL||Loyola University Medical Center||no longer recruiting|
|New Orleans, LA||Ochsner Clinic Foundation||no longer recruiting|
|Annapolis, MD||Anne Arundel Health System Research Institute||no longer recruiting|
|Baltimore, MD||Johns Hopkins Bayview Medical||no longer recruiting|
|Chevy Chase, MD||Metropolitan Gastroenterolgy Group Pc||no longer recruiting|
|Boston, MA||Massachusetts General Hospital||no longer recruiting|
|Boston, MA||Beth Israel Deaconess Med Cntr||no longer recruiting|
|Royal Oak, MI||William Beaumont Hospital||no longer recruiting|
|Chatfield, MN||Mayo Clinic||no longer recruiting|
|St. Louis, MO||Sundance Clinical Research||no longer recruiting|
|Butte, MT||Mercury Street Medical Group||no longer recruiting|
|Englewood Cliffs, NJ||Englewood Hospital and Medical Center||no longer recruiting|
|New York, NY||New York Presbyterian Hospital Weill Cor||no longer recruiting|
|New York, NY||Mount Sinai Hospital||no longer recruiting|
|Rochester, NY||University of Rochester Medical Center||no longer recruiting|
|Cincinnati, OH||University of Cincinnati College of Medicine||no longer recruiting|
|Columbus, OH||Remington-Davis, Inc.||no longer recruiting|
|Lima, OH||Regional Infectious Diseases-Infusion Center Inc||no longer recruiting|
|Philadelphia, PA||Drexel University/Hahnemann University Hospital||no longer recruiting|
|Providence, RI||Brown Alpert Medical School||no longer recruiting|
|Houston, TX||University of Texas School of Public Health||no longer recruiting|
|Lynchburg, VA||Medical Associates of Central Virginia||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Relative risk of recurrence of CDI up to 8 weeks after treatment.
time frame: 8 weeks after treatment.
Time to recurrence of CDI
time frame: Recurrence of CDI up to 4, 8, 12 and 24 weeks after treatment.
Male or female participants at least 18 years old.
Inclusion Criteria: 1. 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. 2. Male or female patients ≥ 18 years. 3. ≥ 3 episodes of CDI within the previous 9 months, inclusive of the current episode with documentation of ≥ 2 episodes. Exclusion Criteria: 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 12 months. 4. 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. 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. 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. 7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).
|Official title||ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection|
|Description||ECOSPOR is a Phase 2, multicenter, randomized, double blind, placebo controlled clinical study with 2 treatment arms (SER-109 or placebo). Patients who have diarrhea and a positive C. difficile test result on a stool sample, and who have responded to standard of care antibiotic treatment will receive study drug on Day 1. Those patients who experience a recurrence of CDI up to 8 weeks after SER 109 or placebo treatment will be offered an opportunity to enroll in an open label SER 109 extension study (Study SERES 005).|
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