Clinical trial NCT05831189: A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
Official title: A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clostridium Difficile Infection Recurrence
Keywords: 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
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 participant will be offered to undergo a structured interview.


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

Primary outcomes:
measure: RBX2660-related treatment-emergent adverse events (TEAEs) after RBX2660 treatment delivered by colonoscopy through 8 weeks, or treatment failure
timeFrame: 8 weeks after RBX2660 treatment delivered by colonoscopy
Secondary outcomes:
measure: Recurrence of Clostridioides difficile infection (CDI) within 8 weeks after RBX2660 treatment delivered by colonoscopy.
timeFrame: Within 8 weeks after RBX2660 treatment delivered by colonoscopy
measure: Time to CDI recurrence from baseline through 8 weeks after RBX2660 treatment delivered by colonoscopy
timeFrame: 8 weeks after RBX2660 treatment delivered by colonoscopy
measure: Physician-experience, as determined by questionnaire, documenting subjective experience of investigators on usability of RBX2660 in clinical practice when delivered by colonoscopy
timeFrame: At Day 1 (baseline visit)
measure: 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
timeFrame: 8 weeks after RBX2660 treatment delivered by colonoscopy
measure: Patient-experience interview at 8 weeks, or at treatment failure, after RBX2660 treatment delivered by colonoscopy
timeFrame: 8 weeks after RBX2660 treatment delivered by colonoscopy
measure: TEAEs, including type, intensity, and causality
timeFrame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
measure: Serious adverse events (SAEs)
timeFrame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
measure: Adverse events of special interest (AESIs): septic shock, toxic megacolon, colonic perforation, and emergency colectomy
timeFrame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
measure: Adverse events leading to death or intensive care unit (ICU) admission
timeFrame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Ferring Investigational Site
state: Arkansas
city: Camarillo
country: United States
facility: Ferring Investigational Site
state: California
city: Hamden
country: United States
facility: Ferring Investigational Site
state: Connecticut
city: Idaho Falls
country: United States
facility: Ferring Investigational Site
state: Idaho
city: Gurnee
country: United States
facility: Ferring Investigational Site
state: Illinois
city: Shreveport
country: United States
facility: Ferring Investigational Site
state: Louisiana
city: Plymouth
country: United States
facility: Ferring Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: Ferring Investigational Site
state: Minnesota
city: Cleveland
country: United States
facility: Ferring Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Ferring Investigational Site
state: Oklahoma
city: Burke
country: United States
facility: Ferring Investigational Site
state: Virginia
city: Madison
country: United States
facility: Ferring Investigational Site
state: Wisconsin
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: