A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection

• Status: Not yet recruiting
• Trial end date: 2024-05-23
• Target enrollment: 0
• Participant gender: All

Summary

This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy. More specifically, the purpose of this trial is to explore the safety and clinical effectiveness of RBX2660 when delivered by colonoscopy to adults with rCDI. The experience of physicians will be documented through a physician-experience questionnaire to explore the usability of RBX2660 in clinical practice for colonoscopic administration. Furthermore, to explore the patient-experience of RBX2660 treatment, each trial subject will be offered to undergo a structured interview.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals

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