REBYOTA™ Prospective Registry

Recruiting

• Conditions: Recurrence of Clostridium Difficile Infection
• Interventions: Drug: REBYOTA™

• Registration Number: NCT05835219
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-28
• Study Start: 2023-06-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Primary Completion: 2026-02-28
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
REBYOTA™	REBYOTA™	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)	8 weeks after initial REBYOTA™ treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Ferring Investigational Site; 🇺🇸 Charlottesville, Virginia, United States

Ferrin Investigational Site; 🇺🇸 Atlanta, Georgia, United States