Your session is about to expire
← Back to Search
Microbiome Restoration Therapy
RBX2660 for C. Diff Infection (CDI-SCOPE Trial)
Phase 3
Recruiting
Research Sponsored by Ferring Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks after rbx2660 treatment delivered by colonoscopy
Awards & highlights
CDI-SCOPE Trial Summary
This trial will explore if RBX2660 is a safe and effective treatment for adults with rCDI when administered via colonoscopy. Doctors and patients will be interviewed to gauge their experience.
Who is the study for?
This trial is for adults with recurrent Clostridioides difficile infection (rCDI), who have had at least one recurrence after the initial episode. Participants must be currently treated with antibiotics for rCDI, confirmed by a stool test, and eligible for fecal microbiota transplantation (FMT) as per US guidelines.Check my eligibility
What is being tested?
The trial tests RBX2660 (REBYOTA®) administered via colonoscopy to assess its safety and effectiveness in treating rCDI. It includes documenting physician experiences through a questionnaire and interviewing patients to understand their treatment experience.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include those typically associated with colonoscopies such as discomfort or pain, bleeding, bowel perforation, and reactions related to the administration of RBX2660.
CDI-SCOPE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 weeks after rbx2660 treatment delivered by colonoscopy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks after rbx2660 treatment delivered by colonoscopy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
RBX2660-related treatment-emergent adverse events (TEAEs) after RBX2660 treatment delivered by colonoscopy through 8 weeks, or treatment failure
Secondary outcome measures
Adverse events leading to death or intensive care unit (ICU) admission
Adverse events of special interest (AESIs): septic shock, toxic megacolon, colonic perforation, and emergency colectomy
Patient-experience interview at 8 weeks, or at treatment failure, after RBX2660 treatment delivered by colonoscopy
+6 moreSide effects data
From 2020 Phase 3 trial • 320 Patients • NCT0324464420%
Diarrhoea
17%
Abdominal pain
10%
Nausea
6%
Abdominal distension
6%
Viral upper respiratory tract infection
6%
Flatulence
4%
Urinary tract infection
4%
Constipation
3%
Depression
2%
Upper respiratory tract infection
2%
Vomiting
1%
Hand fracture
1%
Rib fracture
1%
Failure to thrive
1%
Breast cancer recurrent
1%
Cardio-respiratory arrest
1%
Abdominal abscess
1%
Asthenia
1%
Clostridium difficile colitis
1%
Gait disturbance
1%
Clostridium difficile infection
1%
Confusional state
1%
Acute kidney injury
1%
Ileus
1%
Postoperative ileus
1%
Chronic obstructive pulmonary disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Only
RBX2660 Only
Blinded Placebo/Open-label RBX2660 (Blinded Period)
Blinded RBX2660/Open-label RBX2660 (Blinded Period)
Blinded Placebo/Open-label RBX2660 (Open-label Period)
Blinded RBX2660/Open-label RBX2660 (Open-label Period)
CDI-SCOPE Trial Design
1Treatment groups
Experimental Treatment
Group I: RBX2660Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RBX2660
2017
Completed Phase 3
~1410
Find a Location
Who is running the clinical trial?
Ferring PharmaceuticalsLead Sponsor
313 Previous Clinical Trials
440,818 Total Patients Enrolled
Global Clinical ComplianceStudy DirectorFerring Pharmaceuticals
62 Previous Clinical Trials
357,355 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe bowel inflammation or a current colostomy or ileostomy.I have ongoing severe diarrhea not caused by an infection.I am considered eligible for a fecal transplant to treat my recurrent C. diff infection.I am using or will use antibiotics for a reason other than my current infection.I haven't had a CDI vaccine or antibody treatment in the last year.I am currently on antibiotics for a C. difficile infection confirmed by a stool test.
Research Study Groups:
This trial has the following groups:- Group 1: RBX2660
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the U.S. Food & Drug Administration sanctioned RBX2660?
"There is pre-existing clinical proof of RBX2660's safety, thus it was assigned a 3 on our company's risk assessment scale. This trial has passed multiple stages and data indicates efficacy as well."
Answered by AI
Are there available vacancies for participants in this clinical experiment?
"Affirmative, the available data on clinicaltrials.gov shows that this study is currently seeking enrolment of volunteers. It was initially announced on April 21st 2023 and last updated on April 27th 2023 with a plan to source 40 participants from two different sites."
Answered by AI
What is the upper limit for participants in this clinical experiment?
"Affirmative. Clinicaltrials.gov outlines that this clinical trial is actively enrolling participants; the initial post was on April 21st 2023, and a recent amendment occurred on April 27th 2021. 40 patients are required from 2 sites for successful completion of the study."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger