SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
This trial has been completed.
|Sponsor||Seres Therapeutics, Inc.|
|Start date||May 2015|
|End date||July 2016|
|Trial size||89 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|
|Oceanside, CA||North County Gastroenterology||completed|
|Sacramento, CA||University Of California Davis||completed|
|Ventura, CA||Ventura Clinical Trials||completed|
|Atlantis, FL||ZASA Clinical Research||completed|
|DeBary, FL||Omega Research Consultants LLC||completed|
|Jacksonville, FL||Borland-Groover Clinic||completed|
|Naples, FL||Gastroenterology Group of Naples||completed|
|Port Orange, FL||Advanced Medical Research Center||completed|
|Atlanta, GA||Emory University||completed|
|Idaho Falls, ID||Idaho Falls Infection Diseases||completed|
|New Orleans, LA||Ochsner Clinic Foundation||completed|
|Annapolis, MD||Anne Arundel Health System Research Institute||completed|
|Baltimore, MD||Johns Hopkins Bayview Medical||completed|
|Chevy Chase, MD||Metropolitan Gastroenterolgy Group Pc||completed|
|Boston, MA||Massachusetts General Hospital||completed|
|Boston, MA||Beth Israel Deaconess Med Cntr||completed|
|Royal Oak, MI||William Beaumont Hospital||completed|
|Chatfield, MN||Mayo Clinic||completed|
|St. Louis, MO||Sundance Clinical Research||completed|
|Butte, MT||Mercury Street Medical Group||completed|
|Englewood Cliffs, NJ||Englewood Hospital and Medical Center||completed|
|New York, NY||Mount Sinai Hospital||completed|
|Rochester, NY||University of Rochester Medical Center||completed|
|Cincinnati, OH||University of Cincinnati College of Medicine||completed|
|Columbus, OH||Remington-Davis, Inc.||completed|
|Lima, OH||Regional Infectious Diseases-Infusion Center Inc||completed|
|Philadelphia, PA||Drexel University/Hahnemann University Hospital||completed|
|Providence, RI||Brown Alpert Medical School||completed|
|Houston, TX||University of Texas School of Public Health||completed|
|Lynchburg, VA||Medical Associates of Central Virginia||completed|
|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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