RECRUITING
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REBYOTA™ Prospective Registry
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 Start (Actual) 19 June 2023
🗓️ Primary Completion (Estimated) 7 July 2025
✅ Study Completion (Estimated) 1 August 2025
👥 Enrollment (Estimated) 500
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Chula Vista, California, United States
📍 Murrieta, California, United States
📍 Hamden, Connecticut, United States
📍 Gainesville, Florida, United States
📍 Orlando, Florida, United States
📍 Port Orange, Florida, United States
📍 Tampa, Florida, United States
📍 Zephyrhills, Florida, United States
📍 Atlanta, Georgia, United States
📍 LaGrange, Georgia, United States
📍 Savannah, Georgia, United States
📍 Burr Ridge, Illinois, United States
📍 Iowa City, Iowa, United States
📍 Wichita, Kansas, United States
📍 Jefferson, Louisiana, United States
📍 Boston, Massachusetts, United States
📍 Worcester, Massachusetts, United States
📍 Detroit, Michigan, United States
📍 Farmington Hills, Michigan, United States
📍 Omaha, Nebraska, United States
📍 Teaneck, New Jersey, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Rochester, New York, United States
📍 Stony Brook, New York, United States
📍 Cincinnati, Ohio, United States
📍 Middleburg Heights, Ohio, United States
📍 DuBois, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Charleston, South Carolina, United States
📍 Knoxville, Tennessee, United States
📍 Dallas, Texas, United States
📍 Houston, Texas, United States
📍 West Jordan, Utah, United States
📍 Charlottesville, Virginia, United States
More locations available...

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 18 April 2023
  • First Submitted that Met QC Criteria 18 April 2023
  • First Posted 28 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 June 2024
  • Last Update Posted 11 June 2024
  • Last Verified June 2024
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