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

Phase 2

Completed

• Conditions: Clostridium Difficile
• Interventions: Drug: SER-109; Drug: Placebo

• Registration Number: NCT02437487
• Lead Sponsor: Seres Therapeutics, Inc.

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).

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-07
• Primary Completion: 2016-07
• Study Completion: 2016-10
• Results First Submitted: 2018-05-31
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-27
• Last Update Submitted: 2018-06-27
• Results First Posted: 2018-07-26
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SER-109	SER-109	SER 109 (1 × 108 SporQs)
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Number of Subjects With CDI Recurrence	8 weeks after treatment.

Secondary Outcome Measures

Name	Time	Method
Time to Recurrence of CDI	Recurrence of CDI up to 24 weeks after treatment.	Kaplan-Meier estimate of median number of days to recurrence
Number of Subjects With CDI Recurrence	24 Weeks

Trial Locations

Locations (30)

ZASA Clinical Research; 🇺🇸 Atlantis, Florida, United States

Omega Research Consultants LLC; 🇺🇸 DeBary, Florida, United States

Borland-Groover Clinic; 🇺🇸 Jacksonville, Florida, United States

Gastroenterology Group of Naples; 🇺🇸 Naples, Florida, United States

Mayo Clinic; 🇺🇸 Chatfield, Minnesota, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Idaho Falls Infection Diseases; 🇺🇸 Idaho Falls, Idaho, United States

Johns Hopkins Bayview Medical; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Texas School of Public Health; 🇺🇸 Houston, Texas, United States

North County Gastroenterology; 🇺🇸 Oceanside, California, United States

Ventura Clinical Trials; 🇺🇸 Ventura, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University Of California Davis; 🇺🇸 Sacramento, California, United States

Regional Infectious Diseases-Infusion Center Inc; 🇺🇸 Lima, Ohio, United States

Sundance Clinical Research; 🇺🇸 Saint Louis, Missouri, United States

Medical Associates of Central Virginia; 🇺🇸 Lynchburg, Virginia, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

University of Cincinnati College of Medicine; 🇺🇸 Cincinnati, Ohio, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Anne Arundel Health System Research Institute; 🇺🇸 Annapolis, Maryland, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Brown Alpert Medical School; 🇺🇸 Providence, Rhode Island, United States

Drexel University/Hahnemann University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Advanced Medical Research Center; 🇺🇸 Port Orange, Florida, United States

Metropolitan Gastroenterolgy Group Pc; 🇺🇸 Chevy Chase, Maryland, United States

Mercury Street Medical Group; 🇺🇸 Butte, Montana, United States

Remington-Davis, Inc.; 🇺🇸 Columbus, Ohio, United States

Beth Israel Deaconess Med Cntr; 🇺🇸 Boston, Massachusetts, United States

Englewood Hospital and Medical Center; 🇺🇸 Englewood Cliffs, New Jersey, United States