ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection (ECOSPORIII)
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|ClinicalTrials.gov Identifier: NCT03183128|
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : July 2, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Biological: SER-109 Drug: Placebo||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||July 10, 2017|
|Actual Primary Completion Date :||July 3, 2020|
|Actual Study Completion Date :||September 29, 2020|
Received oral dose of SER-109
SER-109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors
Eubacterial Spores, Purified Suspension, Encapsulated
Placebo Comparator: Placebo
Received matching 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%).
- Recurrence of CDI as determined by a toxin assay up to 8 weeks after initiation of treatment [ Time Frame: Up to Week 8 ]Recurrence of CDI
- Safety and tolerability of SER-109 as assessed by incidence of AEs, lab results, vital signs, and physical examination findings [ Time Frame: Up to Week 24 ]Safety and tolerability of SER-109
- Time to recurrence of CDI from initiation of treatment as determined by a toxin assay [ Time Frame: Up to Week 24 ]Time to recurrence of CDI
- Recurrence of CDI, as determined by a toxin assay, up to 4, 12 and 24 weeks after initiation of treatment in each treatment group [ Time Frame: Up to 4, 12 and 24 weeks after treatment ]Recurrence of CDI
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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
|Study Director:||Lisa von Moltke, MD||Seres Therapeutics, Inc.|
|Responsible Party:||Seres Therapeutics, Inc.|
|Other Study ID Numbers:||
|First Posted:||June 9, 2017 Key Record Dates|
|Last Update Posted:||July 2, 2021|
|Last Verified:||June 2021|
|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|
Gram-Positive Bacterial Infections
Bacterial Infections and Mycoses