An Extension of a Previous Study Evaluating the Use of SER-109 to Prevent Recurrent Clostridium Difficile Infections

Overview

About this study

The purpose of this study is to extend the previous SERES-004 study in patients who had a recurrence of clostridium difficile infection within the first 8 weeks of participation.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Previously enrolled in study SERES 004 and had Clostridium Difficile infection recurrence within 8 weeks after receipt of study drug
  • Signed informed consent, indicating that the patient understands the purpose of and procedures required for the study
  • Antibiotic regimen (for the most recent CDI episode) should be14 days of oral vancomycin (125 mg, q6h) or 10 days of oral fidaxomicin (200 mg, q12h) with adequate clinical response before treatment with SER 109

 

Exclusion Criteria

  • Female patients who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study
  • Known or suspected toxic megacolon and/or known small bowel ileus
  • Active irritable bowel syndrome with diarrhea within the previous 12 months
  • Major GI 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
  • 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
  • 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
  • Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Darrell Pardi, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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