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



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:7/28/2018
Start Date:May 2015
End Date:October 2016

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ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection

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.

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).

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).
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Royal Oak, Michigan 48073
Principal Investigator: Matthew Sims, MD, PhD
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Mark Mulligan, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Elizabeth Hohmann, MD
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
Principal Investigator: Bharat Misra
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
Principal Investigator: Ammar Hemaidan, MD
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Ben Maliakkal, MD
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Annapolis, Maryland 21401
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Atlantis, Florida 33462
Principal Investigator: Debra L Weinstein, MD
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Baltimore, Maryland 21224
Principal Investigator: Jonathan Zenilman, MD
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Boston, Massachusetts 02215
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Butte, Montana 59701
Principal Investigator: John Pullman, MD
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Chatfield, Minnesota 55905
Principal Investigator: Darrell Pardi, MD
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Chevy Chase, Maryland 20815
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Columbus, Ohio 43215
Principal Investigator: Ian Baird, MD, FACP
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Debary, Florida
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Englewood Cliffs, New Jersey 07632
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Houston, Texas 77030
Principal Investigator: Herbert Dupont, MD
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Idaho Falls, Idaho 83404
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Lima, Ohio 45801
Principal Investigator: Ravi Kamepalli, MD, FIDSA, CWS
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Lynchburg, Virginia 24501
Principal Investigator: Robert Brennan, MD, FACS
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Naples, Florida 34102
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New Orleans, Louisiana 70121
Principal Investigator: Julia Garcia-Diaz, MD
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New York, New York 10029
Principal Investigator: Jean Fredric Colombel, MD
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Oceanside, California 92056
Principal Investigator: Matthew Viernes, MD
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19107
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Providence, Rhode Island 02904
Principal Investigator: Colleen Kelly, MD
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
Principal Investigator: Stuart Cohen, MD
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Saint Louis, Missouri 63141
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Ventura, California 93003
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