REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 145
- Locations
- 42
- Primary Endpoint
- Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
REBYOTA™
Intervention: REBYOTA™ (Drug)
Outcomes
Primary Outcomes
Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)
Time Frame: 8 weeks after initial REBYOTA™ treatment
Secondary Outcomes
- Hospitalizations and re-admissions during follow-up for up to 6 months (all-cause and CDI-related) after receiving REBYOTA™(Up to 6 months after receiving REBYOTA™)
- Total number of CDI episodes(6 months after initial REBYOTA™ treatment)
- Time to any CDI episode(6 months 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(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(7 days after REBYOTA™ administration)