Back to resultsECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection (ECOSPORIII)
Primary Purpose
Clostridium Difficile Infection
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SER-109
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Clostridium Difficile Infection
Eligibility Criteria
Main Inclusion Criteria:
- Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject or their legally authorized representative must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.
- Male or female subject ≥ 18 years of age.
A qualifying episode of CDI as defined by:
- ≥ 3 unformed stools per day for 2 consecutive days
- A positive C. difficile stool toxin assay.
- The requirement of CDI SOC antibiotic therapy (defined as 10 to 21 days of treatment with vancomycin [125 mg QID] and/or fidaxomicin [200 mg BID]).
- An adequate clinical response following SOC antibiotic therapy, defined as (<3 unformed stools in 24 hours) for 2 or more consecutive days before randomization.
Main Exclusion Criteria:
- Female subjects who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
- Known or suspected toxic megacolon and/or known small bowel ileus.
- Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Note: nursing homes, rehabilitation, assisted living centers and acute care hospitals are acceptable.
- Absolute neutrophil count of <500 cells/ml^3
- Major gastrointestinal surgery (e.g. 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 (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted).
- History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 3 months.
- Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor).
- Any history of fecal microbiota transplantation (FMT) within the previous 3 months.
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SER-109
Placebo
Arm Description
Received oral dose of SER-109
Received matching placebo
Outcomes
Primary Outcome Measures
Recurrence of CDI up to 8 Weeks
Recurrence of CDI up to 8 Weeks after initiation of treatment. Recurrence was determined by stool Clostridioides difficile toxin assay.
Secondary Outcome Measures
Recurrence of CDI up to 4, 12 and 24 Weeks
Recurrence of CDI up to 4, 12 and 24 Weeks after initiation of treatment. Recurrence was determined by stool Clostridioides difficile toxin assay.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03183128
Brief Title
ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection
Acronym
ECOSPORIII
Official Title
A Phase 3 Multicenter, RandomizeEd, Double Blind, Placebo COntrolled, Parallel Group Study to Evaluate the Safety, Tolerability, & Efficacy of SER-109 vs. Placebo to Reduce Recurrence of ClOstRidium Difficile Infection (CDI) in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
July 3, 2020 (Actual)
Study Completion Date
September 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seres Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CDI as determined by a toxin assay in adults up to 8 weeks after initiation of treatment.
Detailed Description
ECOSPOR III is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, and efficacy of SER-109 versus placebo in adult subjects 18 years of age or older with recurrent CDI, defined as: a history of ≥ 3 CDI episodes within 12 months, inclusive of the current episode. This study is designed to demonstrate the superiority of SER-109 versus placebo to reduce recurrence of Clostridium difficile infection (CDI) in adults who have received antibacterial drug treatment for recurrent CDI (RCDI), based on the proportion of subjects experiencing a CDI recurrence requiring antibiotic treatment up to 8 weeks after initiation of treatment. Approximately 188 subjects with a history of CDI, diarrhea and a positive C. difficile toxin test result on a stool sample, who have responded to standard-of-care (SOC) antibiotic treatment will be enrolled. Subjects will be randomly assigned, in a 1:1 ratio, to 1 of 2 treatment groups (Treatment Group I [SER-109] or Treatment Group II [Placebo]) and stratified by age (<65 years; ≥65 years), as well as antibiotic regimen for the qualifying episode (vancomycin; fidaxomicin).
Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II.
Subjects with confirmed CDI recurrence, as defined in the Protocol, up to 8 weeks after administration of SER-109 or placebo treatment, may be eligible to enroll in the open-label SER-109 extension study (Study SERES-013).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SER-109
Arm Type
Experimental
Arm Description
Received oral dose of SER-109
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Received matching placebo
Intervention Type
Biological
Intervention Name(s)
SER-109
Intervention Description
SER-109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors
Other Names:
Eubacterial Spores, Purified Suspension, Encapsulated
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be identical to the investigational product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline(0.9%).
Primary Outcome Measure Information:
Title
Recurrence of CDI up to 8 Weeks
Description
Recurrence of CDI up to 8 Weeks after initiation of treatment. Recurrence was determined by stool Clostridioides difficile toxin assay.
Time Frame
Up to Week 8
Secondary Outcome Measure Information:
Title
Recurrence of CDI up to 4, 12 and 24 Weeks
Description
Recurrence of CDI up to 4, 12 and 24 Weeks after initiation of treatment. Recurrence was determined by stool Clostridioides difficile toxin assay.
Time Frame
Up to 4, 12 and 24 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject or their legally authorized representative must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.
Male or female subject ≥ 18 years of age.
A qualifying episode of CDI as defined by:
≥ 3 unformed stools per day for 2 consecutive days
A positive C. difficile stool toxin assay.
The requirement of CDI SOC antibiotic therapy (defined as 10 to 21 days of treatment with vancomycin [125 mg QID] and/or fidaxomicin [200 mg BID]).
An adequate clinical response following SOC antibiotic therapy, defined as (<3 unformed stools in 24 hours) for 2 or more consecutive days before randomization.
Main Exclusion Criteria:
Female subjects who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
Known or suspected toxic megacolon and/or known small bowel ileus.
Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Note: nursing homes, rehabilitation, assisted living centers and acute care hospitals are acceptable.
Absolute neutrophil count of <500 cells/ml^3
Major gastrointestinal surgery (e.g. 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 (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted).
History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 3 months.
Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor).
Any history of fecal microbiota transplantation (FMT) within the previous 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa von Moltke, MD
Organizational Affiliation
Seres Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
(Investigator site)
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
(Investigator site)
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Facility Name
(Investigator site)
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
(Investigator site)
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
(Investigator site)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
(Investigator site)
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
(Investigator site)
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
(Investigator site)
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
(Investigator site)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
(Investigator site)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
(Investigator site)
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
(Investigator site)
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
(Investigator site)
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
(Investigator site)
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
(Investigator site)
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
(Investigator site)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
(Investigator site)
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
(Investigator site)
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
(Investigator site)
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
(Investigator site)
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
(Investigator site)
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
(Investigator site)
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
(Investigator site)
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
(Investigator site)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
(Investigator site)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
(Investigator site)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
(Investigator site)
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
(Investigator site)
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
(Investigator site)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02144
Country
United States
Facility Name
(Investigator site)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
(Investigator site)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
(Investigator site)
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
(Investigator site)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
(Investigator site)
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
(Investigator site)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
(Investigator site)
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
(Investigator site)
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
(Investigator site)
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
(Investigator site)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
(Investigator site)
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
(Investigator site)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
(Investigator site)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
(Investigator site)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
(Investigator site)
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
(Investigator site)
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
(Investigator site)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
(Investigator site)
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
(Investigator site)
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
(Investigator site)
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Facility Name
(Investigator site)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
(Investigator site)
City
Reston
State/Province
Virginia
ZIP/Postal Code
20191
Country
United States
Facility Name
(Investigator site)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
(Investigator site)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
(Investigator site)
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
(Investigator site)
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
(Investigator site)
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7Y8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35045228
Citation
Feuerstadt P, Louie TJ, Lashner B, Wang EEL, Diao L, Bryant JA, Sims M, Kraft CS, Cohen SH, Berenson CS, Korman LY, Ford CB, Litcofsky KD, Lombardo MJ, Wortman JR, Wu H, Aunins JG, McChalicher CWJ, Winkler JA, McGovern BH, Trucksis M, Henn MR, von Moltke L. SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection. N Engl J Med. 2022 Jan 20;386(3):220-229. doi: 10.1056/NEJMoa2106516.
Results Reference
derived
Learn more about this trial
ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection
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