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

This study is currently recruiting participants.
Verified June 2017 by Seres Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03183128
First Posted: June 9, 2017
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Seres Therapeutics, Inc.
  Purpose
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 in adults up to 8 weeks after initiation of treatment.

Condition Intervention Phase
Clostridium Difficile Infection Drug: SER-109 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Seres Therapeutics, Inc.:

Primary Outcome Measures:
  • Recurrence of CDI up to 8 weeks after treatment [ Time Frame: Up to Week 8 ]
    Recurrence of CDI


Secondary Outcome Measures:
  • Safety and tolerability of SER-109 as assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings [ Time Frame: Up to Week 24 ]
    Safety and tolerability of SER-109 Safety and tolerability

  • Time to recurrence of CDI [ Time Frame: Up to Week 24 ]
    Time to recurrence of CDI

  • Recurrence of CDI up to 4, 12 and 24 weeks after treatment [ Time Frame: Up to 4, 12 and 24 weeks after treatment ]
    Recurrence of CDI


Estimated Enrollment: 320
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SER-109
SER -109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors
Drug: 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

Placebo Comparator: 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
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.

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 9 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 320 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, and who have completed their Week 8 visit, may be eligible to enroll in the open- label SER-109 extension study (Study SERES-013).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject 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.

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/ml3
  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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183128


Contacts
Contact: Michele Trucksis, PhD, MD 617-203-3367 mtrucksis@serestherapeutics.com

Locations
United States, Montana
Mercury Street Medical Recruiting
Butte, Montana, United States, 59701
Contact: John Pullman, MD    406-723-1300      
Sponsors and Collaborators
Seres Therapeutics, Inc.
Investigators
Study Director: Michele Trucksis, PhD, MD Seres Therapeutics, Inc.
  More Information

Responsible Party: Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03183128     History of Changes
Other Study ID Numbers: SERES-012
First Submitted: June 8, 2017
First Posted: June 9, 2017
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases