REBYOTA™ Prospective Registry (ROAR)

April 15, 2024 updated by: Ferring Pharmaceuticals

REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study

This is a prospective observational cohort study designed to collect data on patients who received REBYOTA™ for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA™ is at the treating physician's discretion and independent from the decision to enroll the patient in the study. Data will be collected from patients' medical records after obtaining informed consent. Data about clinical history, CDI events (primary and recurrent: severity, treatment), CDI-related symptoms, treatments, medical procedures, Adverse Events(AEs), and healthcare resource utilization (i.e., hospitalizations and re-admissions) will be collected through 6 months of follow-up from the date of REBYOTA™ administration.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91910
        • Recruiting
        • Ferring Investigational Site
      • Murrieta, California, United States, 92563
        • Recruiting
        • Ferring Investigational Site
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Recruiting
        • Ferring Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • Ferring Investigational Site
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Ferring Investigational Site
      • Port Orange, Florida, United States, 32127
        • Recruiting
        • Ferring Investigational Site
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Ferring Investigational Site
      • Zephyrhills, Florida, United States, 33542
        • Recruiting
        • Ferring Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Ferrin Investigational Site
      • LaGrange, Georgia, United States, 30240
        • Recruiting
        • Ferring Investigational Site
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Ferring Investigational Site
    • Illinois
      • Burr Ridge, Illinois, United States, 60527
        • Recruiting
        • Ferring Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67211
        • Recruiting
        • Ferring Investigational Site
    • Louisiana
      • Jefferson, Louisiana, United States, 70121
        • Recruiting
        • Ferring Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Ferring Investigational Site
      • Worcester, Massachusetts, United States, 01608
        • Recruiting
        • Ferring Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Ferring Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • Ferring Investigational Site
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • Ferring Investigational Site
      • New York, New York, United States, 10279
        • Recruiting
        • Ferring Investigational Site
      • Rochester, New York, United States, 14618
        • Recruiting
        • Ferring Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • Ferring Investigational Site
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Ferring Investigational Site
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Recruiting
        • Ferring Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Ferring Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • Ferring Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Ferring Investigational Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Ferring Investigational Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Ferring Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who have received antibiotic treatment for Clostridioides Difficile Infection

Description

Inclusion Criteria:

  • Signed and dated informed consent form (ICF)
  • Age ≥ 18 years
  • Diagnosis of rCDI as determined by the treating physician
  • Completed antibiotic treatment for the presenting rCDI episode
  • Prescription for REBYOTA™ to prevent rCDI according to the approved indication

Exclusion Criteria:

  • Currently enrolled in an interventional clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
REBYOTA™
Drug: REBYOTA™
REBYOTA™ is administered in the rectum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)
Time Frame: 8 weeks after initial REBYOTA™ treatment
8 weeks after initial REBYOTA™ treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with sustained clinical response, defined as treatment success of the presenting rCDI episode and no new CDI episodes occurring for more than 8 weeks through 6 months after initial REBYOTA™ treatment
Time Frame: 6 months after initial REBYOTA™ treatment
6 months after initial REBYOTA™ treatment
Total number of CDI episodes
Time Frame: 6 months after initial REBYOTA™ treatment
6 months after initial REBYOTA™ treatment
Time to any CDI episode
Time Frame: 6 months after initial REBYOTA™ treatment
6 months after initial REBYOTA™ treatment
Daily mean changes in Clostridium difficile Infection-Daily Symptoms (CDIDaySyms™) scores from baseline to 7 days after REBYOTA™ administration
Time Frame: 7 days after REBYOTA™ administration
7 days after REBYOTA™ administration
Hospitalizations and re-admissions during follow-up for up to 6 months (all-cause and CDI-related) after receiving REBYOTA™
Time Frame: Up to 6 months after receiving REBYOTA™
Up to 6 months after receiving REBYOTA™

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Investigators

  • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2023

Primary Completion (Estimated)

July 7, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrence of Clostridium Difficile Infection

Clinical Trials on REBYOTA™

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe