REBYOTA™ Prospective Registry

Description

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.

Conditions

Recurrence of Clostridium Difficile Infection

Study Overview

Study Details

Study overview

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.

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

REBYOTA™ Prospective Registry

Condition
Recurrence of Clostridium Difficile Infection
Intervention / Treatment

-

Contacts and Locations

Chula Vista

Ferring Investigational Site, Chula Vista, California, United States, 91910

Murrieta

Ferring Investigational Site, Murrieta, California, United States, 92563

Hamden

Ferring Investigational Site, Hamden, Connecticut, United States, 06518

Gainesville

Ferring Investigational Site, Gainesville, Florida, United States, 32610

Orlando

Ferring Investigational Site, Orlando, Florida, United States, 32806

Port Orange

Ferring Investigational Site, Port Orange, Florida, United States, 32127

Tampa

Ferring Investigational Site, Tampa, Florida, United States, 33614

Zephyrhills

Ferring Investigational Site, Zephyrhills, Florida, United States, 33542

Atlanta

Ferrin Investigational Site, Atlanta, Georgia, United States, 30322

LaGrange

Ferring Investigational Site, LaGrange, Georgia, United States, 30240

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Currently enrolled in an interventional clinical trial

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ferring Pharmaceuticals,

Global Clinical Compliance, STUDY_DIRECTOR, Ferring Pharmaceuticals

Study Record Dates

2025-08-01