Clinical trial NCT02437487: SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
Official title: ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clostridium Difficile
Lead sponsor: Seres Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2015-05-07
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Subjects With CDI Recurrence
timeFrame: 8 weeks after treatment.
Secondary outcomes:
measure: Time to Recurrence of CDI
timeFrame: Recurrence of CDI up to 24 weeks after treatment.
measure: Number of Subjects With CDI Recurrence
timeFrame: 4 Weeks
measure: Number of Subjects With CDI Recurrence
timeFrame: 12 Weeks
measure: Number of Subjects With CDI Recurrence
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: North County Gastroenterology
state: California
city: Sacramento
country: United States
facility: University Of California Davis
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Atlantis
country: United States
facility: ZASA Clinical Research
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants LLC
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Idaho Falls
country: United States
facility: Idaho Falls Infection Diseases
state: Idaho
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Annapolis
country: United States
facility: Anne Arundel Health System Research Institute
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical
state: Maryland
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterolgy Group Pc
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Med Cntr
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Chatfield
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group
state: Montana
city: Englewood Cliffs
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis, Inc.
state: Ohio
city: Lima
country: United States
facility: Regional Infectious Diseases-Infusion Center Inc
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University/Hahnemann University Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Brown Alpert Medical School
state: Rhode Island
city: Houston
country: United States
facility: University of Texas School of Public Health
state: Texas
city: Lynchburg
country: United States
facility: Medical Associates of Central Virginia
state: Virginia
Study officials:
affiliation: Seres Therapeutics
name: Michele Trucksis, Phd, MD
role: STUDY_DIRECTOR
References:
citation: McGovern BH, Ford CB, Henn MR, Pardi DS, Khanna S, Hohmann EL, O'Brien EJ, Desjardins CA, Bernardo P, Wortman JR, Lombardo MJ, Litcofsky KD, Winkler JA, McChalicher CWJ, Li SS, Tomlinson AD, Nandakumar M, Cook DN, Pomerantz RJ, Aunins JG, Trucksis M. SER-109, an Investigational Microbiome Drug to Reduce Recurrence After Clostridioides difficile Infection: Lessons Learned From a Phase 2 Trial. Clin Infect Dis. 2021 Jun 15;72(12):2132-2140. doi: 10.1093/cid/ciaa387.