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

Clostridium Difficile Clinical Trial

— ECOSPOR  

Official title:

ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437487
• Other study ID #: SERES-004
• Status: Completed
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: October 2016

Study information

• Verified date: June 2018
• Source: Seres Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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).

Related Conditions & MeSH terms

• Clostridium Difficile

Intervention

Drug:
• SER-109
SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
• Placebo
Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.

Locations

Country	Name	City	State
United States	Anne Arundel Health System Research Institute	Annapolis	Maryland
United States	Emory University	Atlanta	Georgia
United States	ZASA Clinical Research	Atlantis	Florida
United States	Johns Hopkins Bayview Medical	Baltimore	Maryland
United States	Beth Israel Deaconess Med Cntr	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mercury Street Medical Group	Butte	Montana
United States	Mayo Clinic	Chatfield	Minnesota
United States	Metropolitan Gastroenterolgy Group Pc	Chevy Chase	Maryland
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Remington-Davis, Inc.	Columbus	Ohio
United States	Omega Research Consultants LLC	DeBary	Florida
United States	Englewood Hospital and Medical Center	Englewood Cliffs	New Jersey
United States	University of Texas School of Public Health	Houston	Texas
United States	Idaho Falls Infection Diseases	Idaho Falls	Idaho
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Regional Infectious Diseases-Infusion Center Inc	Lima	Ohio
United States	Medical Associates of Central Virginia	Lynchburg	Virginia
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Mount Sinai Hospital	New York	New York
United States	North County Gastroenterology	Oceanside	California
United States	Drexel University/Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Brown Alpert Medical School	Providence	Rhode Island
United States	University of Rochester Medical Center	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University Of California Davis	Sacramento	California
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Ventura Clinical Trials	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
Seres Therapeutics, Inc.	INC Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With CDI Recurrence		8 weeks after treatment.
Secondary	Time to Recurrence of CDI	Kaplan-Meier estimate of median number of days to recurrence	Recurrence of CDI up to 24 weeks after treatment.
Secondary	Number of Subjects With CDI Recurrence		4 Weeks
Secondary	Number of Subjects With CDI Recurrence		12 Weeks
Secondary	Number of Subjects With CDI Recurrence		24 Weeks