The goal of the Registry is to gain insights that will advance medical knowledge about C.diff infection and the use of REBYOTA in the real world.
About the Registry
The Registry aims to enroll approximately 400 patients from 40 study sites.
See ROAR information on clinicaltrials.gov
REGISTRY OBJECTIVES
The ROAR Registry is a prospective observational cohort study that seeks to document the impact of REBYOTA® in real-world medical practice by capturing data on clinical effectiveness, patient-reported outcomes, healthcare resource utilization, patient characteristics, and safety.
PRIMARY:
To describe the clinical effectiveness through 8 weeks after treatment with REBYOTA in real-world medical practice.
SECONDARY:
- To describe sustained clinical response through 6 months after treatment with REBYOTA in real-world medical practice.
- To describe patient-reported outcomes of REBYOTA in real-world medical practice.
- To describe healthcare resource use in patients who received REBYOTA in real-world medical practice.
- To describe demographic and clinical characteristics of patients who received REBYOTA in real-world medical practice.
OTHER:
- To describe patient experience with REBYOTA in a real-world setting.
- To describe how CDI is managed in real-world clinical practice.
- To estimate the incidence and severity of adverse events in patients who received REBYOTA in real-world clinical practice.
DATA COLLECTION
As an observational study, providers who participate in the ROAR Registry are expected to manage patient care as they would under routine care circumstances.
There are no mandated study visits in the Registry, only data collection timepoints. Patients will also complete questionnaires describing their symptoms and experience.
Adult patients with recurrent C. diff infection (rCDI)
ROUTINE CARE
Presenting episode of rCDI
Completed antibiotic for presenting rCDI episode
REBYOTA prescription 
REBYOTA administration
DATA COLLECTION TIMEPOINTS
CONTINUED ROUTINE MEDICAL CARE...
Week 1
(+5 days)
Week 1
(+14 days)
Primary Objective
Month 6
(+21 days)
End of data collection
PATIENT ELIGIBILITY
The decision to prescribe REBYOTA® for the prevention of rCDI is at the treating provider’s discretion.
Only patients for whom providers have already deemed REBYOTA appropriate are to be approached for participation.
REBYOTA is not supplied as part of the Registry.
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
Scientific Advisory Committee
We are delighted to welcome you to the ROAR study website. This Registry presents an outstanding opportunity to better understand the real-world impact of REBYOTA® (fecal microbiota, live-jslm) in the prevention of recurrence of C. diff infection.
Sponsored by Ferring Pharmaceuticals, the Registry gathers data from physicians and patients to provide critical insights that cannot be gleaned from more controlled clinical trials.
Our role as the Scientific Advisory Committee is to ensure scientific integrity and oversight, share practical perspectives, and assist with data interpretation and publication.
Teena Chopra, MD, MPH
Professor, Infectious Disease Wayne State University
Advisory Committee Chair
Catarina Oneto, MD
Vanguard
Gastroenterology NYU
Grossman
School of Medicine
Kelly Reveles, PharmD, PhD
The University of Texas at Austin
The University of Texas Health San Antonio
Nicholas Van Hise, PharmD, BCPS
Metro Infectious Disease Consultants
ROAR Registry Participating Sites
Are you interested in becoming a ROAR site?
We are looking for:
- Practitioners who treat adult patients with recurrent C. diff
- Can enroll about 10 patients in 18 months
Space is limited!
Publications
We plan to develop a series of publications and presentations from ROAR Registry data.
Please return periodically for details.