COMPLETED

REBYOTA™ Prospective Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-06-19
Study Completion:2025-08-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05835219

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed and dated informed consent form (ICF)
  2. * Age ≥ 18 years
  3. * Diagnosis of rCDI as determined by the treating physician
  4. * Completed antibiotic treatment for the presenting rCDI episode
  5. * Prescription for REBYOTA™ to prevent rCDI according to the approved indication
  1. * Currently enrolled in an interventional clinical trial

Contacts and Locations

Principal Investigator

Global Clinical Compliance
STUDY_DIRECTOR
Ferring Pharmaceuticals

Study Locations (Sites)

Ferring Investigational Site
Chandler, Arizona, 85224
United States
Ferring Investigational Site
Chula Vista, California, 91910
United States
Ferring Investigational Site
Murrieta, California, 92563
United States
Ferring Investigational Site
Oceanside, California, 92054
United States
Ferring Investigational Site
Sacramento, California, 95816
United States
Ferring Investigational Site
Hamden, Connecticut, 06518
United States
Ferring Investigational Site
Gainesville, Florida, 32610
United States
Ferring Investigational Site
Orlando, Florida, 32806
United States
Ferring Investigational Site
Port Orange, Florida, 32127
United States
Ferring Investigational Site
Tampa, Florida, 33614
United States
Ferring Investigational Site
Zephyrhills, Florida, 33542
United States
Ferrin Investigational Site
Atlanta, Georgia, 30322
United States
Ferring Investigational Site
La Grange, Georgia, 30240
United States
Ferring Investigational Site
Savannah, Georgia, 31405
United States
Ferring Investigational Site
Burr Ridge, Illinois, 60527
United States
Ferring Investigational Site
Maywood, Illinois, 60153
United States
Ferring Investigational Site
Iowa City, Iowa, 52242
United States
Ferring Investigational Site
Wichita, Kansas, 67211
United States
Ferring Investigational Site
Jefferson, Louisiana, 70121
United States
Ferring Investigational Site
Boston, Massachusetts, 02115
United States
Ferring Investigational Site
Worcester, Massachusetts, 01608
United States
Ferring Investigational Site
Detroit, Michigan, 48201
United States
Ferring Investigational Site
Detroit, Michigan, 48202
United States
Ferring Investigational Site
Farmington Hills, Michigan, 48336
United States
Ferring Investigational Site
Omaha, Nebraska, 68198
United States
Ferring Investigational Site
Teaneck, New Jersey, 07666
United States
Ferring Investigational Site
New York, New York, 10016
United States
Ferring Investigational Site
New York, New York, 10021
United States
Ferring Investigational Site
New York, New York, 10279
United States
Ferring Investigational Site
Rochester, New York, 14618
United States
Ferring Investigational Site
Stony Brook, New York, 11794
United States
Ferring Investigational Site
Fargo, North Dakota, 58122
United States
Ferring Investigational Site
Cincinnati, Ohio, 45267
United States
Ferring Investigational Site
Middleburg Heights, Ohio, 44130
United States
Ferring Investigational Site
DuBois, Pennsylvania, 15801
United States
Ferring Investigational Site
Pittsburgh, Pennsylvania, 15237
United States
Ferring Investigational Site
Charleston, South Carolina, 29425
United States
Ferring Investigational Site
Knoxville, Tennessee, 37909
United States
Ferring Investigational Site
Dallas, Texas, 75246
United States
Ferring Investigational Site
Houston, Texas, 77030
United States
Ferring Investigational Site
West Jordan, Utah, 84088
United States
Ferring Investigational Site
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Ferring Pharmaceuticals

  • Global Clinical Compliance, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2023-06-19
Study Completion Date2025-08-29

Study Record Updates

Study Start Date2023-06-19
Study Completion Date2025-08-29

Terms related to this study

Additional Relevant MeSH Terms

  • Recurrence of Clostridium Difficile Infection