A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection (CDI-SCOPE)
Clostridium Difficile Infection Recurrence
About this trial
This is an interventional treatment trial for Clostridium Difficile Infection Recurrence focused on measuring C. Difficile Diarrhea, Clostridium Difficile, CDI, FMT, Fecal Microbiota Transplant, Microbiota Restoration Therapy, Diarrhea, Microbial Suspension, Fecal Transplant, C Difficile Colitis, Clostridium Difficile Associated Diarrhea, C diff diarrhea, C Difficile, C diff
Eligibility Criteria
Inclusion Criteria: have documented evidence of rCDI (≥1 recurrence after a primary CDI episode) be undergoing antibiotic treatment for the qualifying rCDI episode that was diagnosed by a stool test for the presence of toxigenic C. difficile or C. difficile toxin be eligible for FMT as judged by the investigator or current treatment guidelines for rCDI in the US be a candidate for colonoscopy as judged by the investigator Exclusion Criteria: Use or planned use of systemic antibiotics for an indication other than the qualifying rCDI episode. Current uncontrolled chronic diarrhea not related to CDI. Receipt of CDI vaccine or treatment with CDI monoclonal antibodies within the past 12 months before screening. Evidence of active, severe, or fulminant colitis, diagnosis of toxic megacolon or have a current colostomy or ileostomy
Sites / Locations
- Ferring Investigational SiteRecruiting
- Ferring Investigational SiteRecruiting
- Ferring Investigational SiteRecruiting
- Ferring Investigational SiteRecruiting
- Ferring Investigational SiteRecruiting
- Ferring Investigational SiteRecruiting
- Ferring Investigational SiteRecruiting
- Ferring Investigational SiteRecruiting
- Ferring Investigational SiteRecruiting
- Ferring Investigational SiteRecruiting
Arms of the Study
Arm 1
Experimental
RBX2660