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 Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05831189
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ferring Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Global Clinical Compliance
Principal Investigator Affiliation Ferring Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Clostridium Difficile Infection Recurrence
Arms & Interventions

Arms

Experimental: RBX2660

Interventions

Drug: - RBX2660

RBX2660 should be administered to the right side of the colon (i.e., between the ileocecal valve and the hepatic flexure of the colon).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Ferring Investigational Site, North Little Rock, Arkansas

Status

Recruiting

Address

Ferring Investigational Site

North Little Rock, Arkansas, 72117

Ferring Investigational Site, Camarillo, California

Status

Recruiting

Address

Ferring Investigational Site

Camarillo, California, 93012

Ferring Investigational Site, Hamden, Connecticut

Status

Recruiting

Address

Ferring Investigational Site

Hamden, Connecticut, 06518

Ferring Investigational Site, Idaho Falls, Idaho

Status

Recruiting

Address

Ferring Investigational Site

Idaho Falls, Idaho, 83404

Ferring Investigational Site, Shreveport, Louisiana

Status

Recruiting

Address

Ferring Investigational Site

Shreveport, Louisiana, 71105

Ferring Investigational Site, Plymouth, Minnesota

Status

Recruiting

Address

Ferring Investigational Site

Plymouth, Minnesota, 55446

Ferring Investigational Site, Rochester, Minnesota

Status

Recruiting

Address

Ferring Investigational Site

Rochester, Minnesota, 55905

Ferring Investigational Site, Oklahoma City, Oklahoma

Status

Recruiting

Address

Ferring Investigational Site

Oklahoma City, Oklahoma, 73102

Ferring Investigational Site, Burke, Virginia

Status

Recruiting

Address

Ferring Investigational Site

Burke, Virginia, 22015

Ferring Investigational Site, Madison, Wisconsin

Status

Recruiting

Address

Ferring Investigational Site

Madison, Wisconsin, 53705