REBYOTA™ Prospective Registry (ROAR)

Ferring

Status: Enrolling

Conditions: Recurrence of Clostridium Difficile Infection

Treatments: Drug: REBYOTA™

Study type: Observational

Funder types: Industry

Identifiers

NCT05835219

000422

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

REBYOTA™

Treatment:

Drug: REBYOTA™