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 Type
OBSERVATIONAL
Enrollment
145
REBYOTA™ is administered in the rectum
Ferring Investigational Site
Chandler, Arizona, United States
Ferring Investigational Site
Chula Vista, California, United States
Ferring Investigational Site
Murrieta, California, United States
Ferring Investigational Site
Oceanside, California, United States
Ferring Investigational Site
Sacramento, California, United States
Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)
Time frame: 8 weeks after initial REBYOTA™ treatment
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
Total number of CDI episodes
Time frame: 6 months after initial REBYOTA™ treatment
Time to any CDI episode
Time frame: 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
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™
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Ferring Investigational Site
Hamden, Connecticut, United States
Ferring Investigational Site
Gainesville, Florida, United States
Ferring Investigational Site
Orlando, Florida, United States
Ferring Investigational Site
Port Orange, Florida, United States
Ferring Investigational Site
Tampa, Florida, United States
...and 32 more locations