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)

Ferring

Status and phase

Completed

Phase 3

Conditions

Clostridium Difficile Infection Recurrence

Treatments

Drug: RBX2660

Study type

Interventional

Funder types

Industry

Identifiers

NCT05831189

000416

Details and patient eligibility

About

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 participant will be offered to undergo a structured interview.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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