Clinical trial NCT05835219: REBYOTA™ Prospective Registry
Official title: REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Recurrence of Clostridium Difficile Infection
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-04-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have received antibiotic treatment for Clostridioides Difficile Infection

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)
timeFrame: 8 weeks after initial REBYOTA™ treatment
Secondary outcomes:
measure: 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
timeFrame: 6 months after initial REBYOTA™ treatment
measure: Total number of CDI episodes
timeFrame: 6 months after initial REBYOTA™ treatment
measure: Time to any CDI episode
timeFrame: 6 months after initial REBYOTA™ treatment
measure: Daily mean changes in Clostridium difficile Infection-Daily Symptoms (CDIDaySyms™) scores from baseline to 7 days after REBYOTA™ administration
timeFrame: 7 days after REBYOTA™ administration
measure: Hospitalizations and re-admissions during follow-up for up to 6 months (all-cause and CDI-related) after receiving REBYOTA™
timeFrame: Up to 6 months after receiving REBYOTA™
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ferring Investigational Site
state: Arizona
city: Chula Vista
country: United States
facility: Ferring Investigational Site
state: California
city: Murrieta
country: United States
facility: Ferring Investigational Site
state: California
city: Oceanside
country: United States
facility: Ferring Investigational Site
state: California
city: Sacramento
country: United States
facility: Ferring Investigational Site
state: California
city: Hamden
country: United States
facility: Ferring Investigational Site
state: Connecticut
city: Gainesville
country: United States
facility: Ferring Investigational Site
state: Florida
city: Orlando
country: United States
facility: Ferring Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Ferring Investigational Site
state: Florida
city: Tampa
country: United States
facility: Ferring Investigational Site
state: Florida
city: Zephyrhills
country: United States
facility: Ferring Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Ferrin Investigational Site
state: Georgia
city: LaGrange
country: United States
facility: Ferring Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Ferring Investigational Site
state: Georgia
city: Burr Ridge
country: United States
facility: Ferring Investigational Site
state: Illinois
city: Maywood
country: United States
facility: Ferring Investigational Site
state: Illinois
city: Iowa City
country: United States
facility: Ferring Investigational Site
state: Iowa
city: Wichita
country: United States
facility: Ferring Investigational Site
state: Kansas
city: Jefferson
country: United States
facility: Ferring Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Ferring Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Ferring Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Ferring Investigational Site
state: Michigan
city: Detroit
country: United States
facility: Ferring Investigational Site
state: Michigan
city: Farmington Hills
country: United States
facility: Ferring Investigational Site
state: Michigan
city: Omaha
country: United States
facility: Ferring Investigational Site
state: Nebraska
city: Teaneck
country: United States
facility: Ferring Investigational Site
state: New Jersey
city: New York
country: United States
facility: Ferring Investigational Site
state: New York
city: New York
country: United States
facility: Ferring Investigational Site
state: New York
city: New York
country: United States
facility: Ferring Investigational Site
state: New York
city: Rochester
country: United States
facility: Ferring Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Ferring Investigational Site
state: New York
city: Fargo
country: United States
facility: Ferring Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: Ferring Investigational Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Ferring Investigational Site
state: Ohio
city: DuBois
country: United States
facility: Ferring Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Ferring Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Ferring Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: Ferring Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Ferring Investigational Site
state: Texas
city: Houston
country: United States
facility: Ferring Investigational Site
state: Texas
city: West Jordan
country: United States
facility: Ferring Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: Ferring Investigational Site
state: Virginia
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: