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 |
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.
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).
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).
We found this trial at
30
sites
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201 Dowman Dr
Atlanta, Georgia 30303
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
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Elizabeth Hohmann, MD
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Principal Investigator: Bharat Misra
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
Port Orange, Florida 32127
Principal Investigator: Ammar Hemaidan, MD
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Ben Maliakkal, MD
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Annapolis, Maryland 21401
Principal Investigator: James Welker
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Baltimore, Maryland 21224
Principal Investigator: Jonathan Zenilman, MD
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Boston, Massachusetts 02215
Principal Investigator: Carolyn Alonso, MD
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Chevy Chase, Maryland 20815
Principal Investigator: Robert Hardi, MD
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Cincinnati, Ohio 45267
Principal Investigator: Senu Apewokin
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Englewood Cliffs, New Jersey 07632
Principal Investigator: Mitchell Spinnell, MD
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Houston, Texas 77030
Principal Investigator: Herbert Dupont, MD
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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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New Orleans, Louisiana 70121
Principal Investigator: Julia Garcia-Diaz, MD
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Oceanside, California 92056
Principal Investigator: Matthew Viernes, MD
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Principal Investigator: Neilanjan Nandi, MD
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Providence, Rhode Island 02904
Principal Investigator: Colleen Kelly, MD
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1 Shields Ave
Sacramento, California 95616
Sacramento, California 95616
(530) 752-1011
Principal Investigator: Stuart Cohen, MD
University of California-Davis As we begin our second century, UC Davis is poised to become...
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