Expanded Access and Open Label Extension Study of SER-109 to Prevent Recurrent Clostridium Difficile Infection

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label study for patients who have a recurrence of Clostridium difficile infection in the first 8 weeks of participation in the SERES-004 study. As the SERES-004 study has completed enrollment, SERES-005 was amended to allow expanded access in accordance with 21 CFR 312.315 to SER-109 for patients with recurrent CDI who would have qualified for the SERES-004 study.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seres Therapeutics, Inc.
• Collaborators: INC Research; Syneos Health

Criteria

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 of age.

3. Previously enrolled in Study SERES-004 and had CDI recurrence within 8 weeks after receipt of study drug, OR If not previously enrolled in Study SERES-004, a documented history of ≥ 3 episodes of CDI within the previous 9 months, inclusive of the current episode with ≥ 1 of the historical episodes having the date, test results, and antibiotic treatment received documented. Efforts should be made to acquire history of additional CDI episodes.

4. If not previously enrolled in Study SERES-004, a qualifying episode of CDI as defined by:

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

2. A positive C. difficile stool test

3. The requirement of CDI standard-of-care antibiotic therapy (defined as 10 to 21 days of treatment with vancomycin or fidaxomicin but excluding pulse-tapered antibiotic regimens).

4. An adequate clinical response defined as no evidence of diarrhea (< 3 unformed stools in 24 hours) for 2 or more consecutive days before randomization.

5. If female, patient is non-lactating, and is either:

1. Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.

2. Of childbearing potential and is practicing at least 1 highly effective method of birth control including the barrier method; oral or parenteral contraceptives; a vasectomized partner; or abstinence from sexual intercourse. The investigator will discuss with the patient the option of practicing more than 1 of the above methods for the duration of the study.

6. If male and partner is of childbearing potential, patient agrees to practice at least 1 highly effective method of birth control for the duration of the study.

7. Is not taking probiotics, or discontinues probiotics prior to study start and will not take probiotics for the duration of the study.

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. 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.

5. Taking antibacterial therapy other than vancomycin (non-tapered) or fidaxomicin for most recent episode of CDI within 14 days before enrollment. A single-day antibiotic prophylactic regimen is permitted.

6. Use of any probiotics.

7. 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.

8. 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.

9. Unable to stop loperamide, diphenoxylate/atropine, or cholestyramine before the study.

10. Unable to stop opiate treatment unless on a stable dose, including PRN dosing, as of onset of diarrhea and no increase in dose planned for the duration of the study.

11. Known positive stool cultures for other enteropathogens including, but not limited to, Salmonella, Shigella, and Campylobacter within the 30 days before enrollment.

12. Known stool studies positive for ova and/or parasites within the 30 days before enrollment.

13. Poor concurrent medical risks with clinically significant co-morbid disease such that, in the opinion of the investigator, the patient should not be enrolled.

14. Received an investigational vaccine against C. difficile.

15. Known active intravenous drug or alcohol abuse or other drugs of abuse.