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

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.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile
• Intervention / Treatment: Drug: SER-109; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Oceanside, California, United States, 92056
      • North County Gastroenterology
    • Sacramento, California, United States, 95817
      • University of California Davis
    • Ventura, California, United States, 93003
      • Ventura Clinical Trials
  • Florida
    • Atlantis, Florida, United States, 33462
      • Zasa Clinical Research
    • DeBary, Florida, United States, 32713
      • Omega Research Consultants LLC
    • Jacksonville, Florida, United States, 33256
      • Borland-Groover Clinic
    • Naples, Florida, United States, 34102
      • Gastroenterology Group of Naples
    • Port Orange, Florida, United States, 32127
      • Advanced Medical Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Idaho Falls Infection Diseases
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Maryland
    • Annapolis, Maryland, United States, 21410
      • Anne Arundel Health System Research Institute
    • Baltimore, Maryland, United States, 21224-2780
      • Johns Hopkins Bayview Medical
    • Chevy Chase, Maryland, United States, 20815
      • Metropolitan Gastroenterolgy Group Pc
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Med Cntr
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Chatfield, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical Group
  • New Jersey
    • Englewood Cliffs, New Jersey, United States, 07632-2514
      • Englewood Hospital and Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati College of Medicine
    • Columbus, Ohio, United States, 43215
      • Remington-Davis, Inc.
    • Lima, Ohio, United States, 45801
      • Regional Infectious Diseases-Infusion Center Inc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Drexel University/Hahnemann University Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Brown Alpert Medical School
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas School of Public Health
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Medical Associates of Central Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
EXPERIMENTAL: SER-109; SER 109 (1 × 108 SporQs)	Drug: SER-109; SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.; Other Names: Purified Eubacterial Spores, Encapsulated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Subjects With CDI Recurrence	8 weeks after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Recurrence of CDI	Kaplan-Meier estimate of median number of days to recurrence	Recurrence of CDI up to 24 weeks after treatment.
Number of Subjects With CDI Recurrence		4 Weeks
Number of Subjects With CDI Recurrence		12 Weeks
Number of Subjects With CDI Recurrence		24 Weeks

Collaborators and Investigators

• Sponsor: Seres Therapeutics, Inc.
• Collaborators: Syneos Health
• Investigators: Study Director: Michele Trucksis, Phd, MD, Seres Therapeutics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: May 5, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (ESTIMATE): May 7, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections
• Other Study ID Numbers: SERES-004