← Back to Search

Other

REBYOTA™ for Clostridium Difficile (ROAR Trial)

N/A
Recruiting
Research Sponsored by Ferring Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after rebyota™ administration
Awards & highlights

ROAR Trial 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.

Eligible Conditions
  • Clostridium Difficile

ROAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after rebyota™ administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after rebyota™ administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)
Secondary outcome measures
Daily mean changes in Clostridium difficile Infection-Daily Symptoms (CDIDaySyms™) scores from baseline to 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™
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
+2 more

ROAR Trial Design

1Treatment groups
Experimental Treatment
Group I: REBYOTA™Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Ferring PharmaceuticalsLead Sponsor
313 Previous Clinical Trials
440,358 Total Patients Enrolled
Global Clinical ComplianceStudy DirectorFerring Pharmaceuticals
62 Previous Clinical Trials
356,895 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~292 spots leftby Jul 2025