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

Ferring Pharmaceuticals41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Clostridium Difficile Infection Recurrence

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Ferring Investigational Site

North Little Rock, Arkansas, United States

Ferring Investigational Site

Camarillo, California, United States

Ferring Investigational Site

Hamden, Connecticut, United States

Ferring Investigational Site

Idaho Falls, Idaho, United States

Ferring Investigational Site

Gurnee, Illinois, United States

Ferring Investigational Site

Shreveport, Louisiana, United States

Ferring Investigational Site

Plymouth, Minnesota, United States

Ferring Investigational Site

Rochester, Minnesota, United States

Ferring Investigational Site

Cleveland, Ohio, United States

Ferring Investigational Site

Oklahoma City, Oklahoma, United States

...and 2 more locations

Outcomes

Primary Outcomes

RBX2660-related treatment-emergent adverse events (TEAEs) after RBX2660 treatment delivered by colonoscopy through 8 weeks, or treatment failure

Time frame: 8 weeks after RBX2660 treatment delivered by colonoscopy

Secondary Outcomes

Recurrence of Clostridioides difficile infection (CDI) within 8 weeks after RBX2660 treatment delivered by colonoscopy.

Time frame: Within 8 weeks after RBX2660 treatment delivered by colonoscopy

Time to CDI recurrence from baseline through 8 weeks after RBX2660 treatment delivered by colonoscopy

Time frame: 8 weeks after RBX2660 treatment delivered by colonoscopy

Physician-experience, as determined by questionnaire, documenting subjective experience of investigators on usability of RBX2660 in clinical practice when delivered by colonoscopy

Time frame: At Day 1 (baseline visit)

Physician perception of patient benefit, as determined by Clinician Global Impression of Improvement (CGI-I) at 8 weeks, or at treatment failure, after RBX2660 treatment delivered by colonoscopy

Time frame: 8 weeks after RBX2660 treatment delivered by colonoscopy

Patient-experience interview at 8 weeks, or at treatment failure, after RBX2660 treatment delivered by colonoscopy

Time frame: 8 weeks after RBX2660 treatment delivered by colonoscopy

TEAEs, including type, intensity, and causality

Time frame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy

Serious adverse events (SAEs)

Time frame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy

Adverse events of special interest (AESIs): septic shock, toxic megacolon, colonic perforation, and emergency colectomy

Time frame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy

Adverse events leading to death or intensive care unit (ICU) admission

Time frame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy