ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection

Clostridium Difficile Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183128
• Other study ID #: SERES-012
• Status: Completed
• Phase: Phase 3
• Start date: July 10, 2017
• Est. completion date: September 29, 2020

Study information

• Verified date: June 2021
• Source: Seres Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 29, 2020
• Est. primary completion date: July 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

1. 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.

2. Male or female subject = 18 years of age.

3. A qualifying episode of CDI as defined by:

1. = 3 unformed stools per day for 2 consecutive days

2. A positive C. difficile stool toxin assay.

3. 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]).

4. 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:

1. Female subjects 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. 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.

4. Absolute neutrophil count of <500 cells/ml^3

5. 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).

6. 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.

7. 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).

8. Any history of fecal microbiota transplantation (FMT) within the previous 3 months.

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections

Intervention

Biological:
• SER-109
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

Drug:
• Placebo
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%).

Locations

Country	Name	City	State
Canada	(Investigator site)	Calgary	Alberta
Canada	(Investigator site)	Chicoutimi	Quebec
Canada	(Investigator site)	London	Ontario
Canada	(Investigator site)	Vancouver	British Columbia
Canada	(Investigator site)	Victoria	British Columbia
United States	(Investigator site)	Annapolis	Maryland
United States	(Investigator site)	Athens	Georgia
United States	(Investigator site)	Atlanta	Georgia
United States	(Investigator site)	Boston	Massachusetts
United States	(Investigator site)	Bountiful	Utah
United States	(Investigator site)	Buffalo	New York
United States	(Investigator site)	Butte	Montana
United States	(Investigator site)	Centerville	Ohio
United States	(Investigator site)	Charlottesville	Virginia
United States	(Investigator site)	Chevy Chase	Maryland
United States	(Investigator site)	Cleveland	Ohio
United States	(Investigator site)	Columbus	Ohio
United States	(Investigator site)	Detroit	Michigan
United States	(Investigator site)	Evansville	Indiana
United States	(Investigator site)	Greenville	North Carolina
United States	(Investigator site)	Hamden	Connecticut
United States	(Investigator site)	Houston	Texas
United States	(Investigator site)	Idaho Falls	Idaho
United States	(Investigator site)	Iowa City	Iowa
United States	(Investigator site)	Jacksonville	Florida
United States	(Investigator site)	Jeffersonville	Indiana
United States	(Investigator site)	Kansas City	Kansas
United States	(Investigator site)	Kinston	North Carolina
United States	(Investigator site)	Las Vegas	Nevada
United States	(Investigator site)	Marietta	Georgia
United States	(Investigator site)	Mather	California
United States	(Investigator site)	Miami	Florida
United States	(Investigator site)	Miami	Florida
United States	(Investigator site)	Mountain View	California
United States	(Investigator site)	New Orleans	Louisiana
United States	(Investigator site)	North Little Rock	Arkansas
United States	(Investigator site)	Northridge	California
United States	(Investigator site)	Pembroke Pines	Florida
United States	(Investigator site)	Pembroke Pines	Florida
United States	(Investigator site)	Pittsburgh	Pennsylvania
United States	(Investigator site)	Raleigh	North Carolina
United States	(Investigator site)	Reston	Virginia
United States	(Investigator site)	Riverdale	Georgia
United States	(Investigator site)	Riverton	Utah
United States	(Investigator site)	Royal Oak	Michigan
United States	(Investigator site)	Sacramento	California
United States	(Investigator site)	Saint Louis	Missouri
United States	(Investigator site)	San Antonio	Texas
United States	(Investigator site)	Sandy Springs	Georgia
United States	(Investigator site)	Sayre	Pennsylvania
United States	(Investigator site)	Simi Valley	California
United States	(Investigator site)	Southlake	Texas
United States	(Investigator site)	Springfield	Illinois
United States	(Investigator site)	Upland	California
United States	(Investigator site)	Washington	District of Columbia
United States	(Investigator site)	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Seres Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Week 8
Secondary	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.	Up to 4, 12 and 24 weeks after treatment