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ROAR: REBYOTA™ Prospective Registry

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05835219
Collaborator
(none)
500
Enrollment
23.2
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study
Anticipated Study Start Date :
May 31, 2023
Anticipated Primary Completion Date :
May 5, 2025
Anticipated Study Completion Date :
May 5, 2025

Arms and Interventions

Arm Intervention/Treatment
REBYOTA™

Drug: REBYOTA™
REBYOTA™ is administered in the rectum

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

  2. Total number of CDI episodes [6 months after initial REBYOTA™ treatment]

  3. Time to any CDI episode [6 months after initial REBYOTA™ treatment]

  4. Daily mean changes in Clostridium difficile Infection-Daily Symptoms (CDIDaySyms™) scores from baseline to 7 days after REBYOTA™ administration [7 days after REBYOTA™ administration]

  5. 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™]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ferring Pharmaceuticals

Investigators

  • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05835219
Other Study ID Numbers:
  • 000422
First Posted:
Apr 28, 2023
Last Update Posted:
May 5, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
Clostridium Infections
Recurrence

Study Results

No Results Posted as of May 5, 2023