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

Primary Purpose

Clostridium Difficile

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SER-109
Placebo
Sponsored by
Seres Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • North County Gastroenterology
  • University Of California Davis
  • Ventura Clinical Trials
  • ZASA Clinical Research
  • Omega Research Consultants LLC
  • Borland-Groover Clinic
  • Gastroenterology Group of Naples
  • Advanced Medical Research Center
  • Emory University
  • Idaho Falls Infection Diseases
  • Ochsner Clinic Foundation
  • Anne Arundel Health System Research Institute
  • Johns Hopkins Bayview Medical
  • Metropolitan Gastroenterolgy Group Pc
  • Massachusetts General Hospital
  • Beth Israel Deaconess Med Cntr
  • William Beaumont Hospital
  • Mayo Clinic
  • Sundance Clinical Research
  • Mercury Street Medical Group
  • Englewood Hospital and Medical Center
  • Mount Sinai Hospital
  • University of Rochester Medical Center
  • University of Cincinnati College of Medicine
  • Remington-Davis, Inc.
  • Regional Infectious Diseases-Infusion Center Inc
  • Drexel University/Hahnemann University Hospital
  • Brown Alpert Medical School
  • University of Texas School of Public Health
  • Medical Associates of Central Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SER-109

Placebo

Arm Description

SER 109 (1 × 108 SporQs)

Placebo

Outcomes

Primary Outcome Measures

Number of Subjects With CDI Recurrence

Secondary Outcome Measures

Time to Recurrence of CDI
Kaplan-Meier estimate of median number of days to recurrence
Number of Subjects With CDI Recurrence
Number of Subjects With CDI Recurrence
Number of Subjects With CDI Recurrence

Full Information

First Posted
May 5, 2015
Last Updated
June 27, 2018
Sponsor
Seres Therapeutics, Inc.
Collaborators
Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT02437487
Brief Title
SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
Acronym
ECOSPOR
Official Title
ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seres Therapeutics, Inc.
Collaborators
Syneos Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SER-109
Arm Type
Experimental
Arm Description
SER 109 (1 × 108 SporQs)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
SER-109
Other Intervention Name(s)
Purified Eubacterial Spores, Encapsulated
Intervention Description
SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Subjects With CDI Recurrence
Time Frame
8 weeks after treatment.
Secondary Outcome Measure Information:
Title
Time to Recurrence of CDI
Description
Kaplan-Meier estimate of median number of days to recurrence
Time Frame
Recurrence of CDI up to 24 weeks after treatment.
Title
Number of Subjects With CDI Recurrence
Time Frame
4 Weeks
Title
Number of Subjects With CDI Recurrence
Time Frame
12 Weeks
Title
Number of Subjects With CDI Recurrence
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Male or female patients ≥ 18 years. ≥ 3 episodes of CDI within the previous 9 months, inclusive of the current episode with documentation of ≥ 2 episodes. Exclusion Criteria: Female patients who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study. Known or suspected toxic megacolon and/or known small bowel ileus. Active irritable bowel syndrome with diarrhea within the previous 12 months. 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. 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. 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. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Trucksis, Phd, MD
Organizational Affiliation
Seres Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
North County Gastroenterology
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
University Of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
ZASA Clinical Research
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Omega Research Consultants LLC
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
33256
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Advanced Medical Research Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Idaho Falls Infection Diseases
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Anne Arundel Health System Research Institute
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21410
Country
United States
Facility Name
Johns Hopkins Bayview Medical
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224-2780
Country
United States
Facility Name
Metropolitan Gastroenterolgy Group Pc
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Med Cntr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Mayo Clinic
City
Chatfield
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Sundance Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercury Street Medical Group
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood Cliffs
State/Province
New Jersey
ZIP/Postal Code
07632-2514
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Remington-Davis, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Regional Infectious Diseases-Infusion Center Inc
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Drexel University/Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Brown Alpert Medical School
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
University of Texas School of Public Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical Associates of Central Virginia
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32255488
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.
Results Reference
derived

Learn more about this trial

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

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