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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REBYOTA™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REBYOTA™ | Drug | REBYOTA™ is administered in the rectum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician) | 8 weeks after initial REBYOTA™ treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Total number of CDI episodes |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have received antibiotic treatment for Clostridioides Difficile Infection
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferring Investigational Site | Chandler | Arizona | 85224 | United States | ||
| Ferring Investigational Site |
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| 6 months after initial REBYOTA™ treatment |
| Time to any CDI episode | 6 months after initial REBYOTA™ treatment |
| Daily mean changes in Clostridium difficile Infection-Daily Symptoms (CDIDaySyms™) scores from baseline to 7 days after REBYOTA™ administration | 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™ | Up to 6 months after receiving REBYOTA™ |
| Chula Vista |
| California |
| 91910 |
| United States |
| Ferring Investigational Site | Murrieta | California | 92563 | United States |
| Ferring Investigational Site | Oceanside | California | 92054 | United States |
| Ferring Investigational Site | Sacramento | California | 95816 | United States |
| Ferring Investigational Site | Hamden | Connecticut | 06518 | United States |
| Ferring Investigational Site | Gainesville | Florida | 32610 | United States |
| Ferring Investigational Site | Orlando | Florida | 32806 | United States |
| Ferring Investigational Site | Port Orange | Florida | 32127 | United States |
| Ferring Investigational Site | Tampa | Florida | 33614 | United States |
| Ferring Investigational Site | Zephyrhills | Florida | 33542 | United States |
| Ferrin Investigational Site | Atlanta | Georgia | 30322 | United States |
| Ferring Investigational Site | La Grange | Georgia | 30240 | United States |
| Ferring Investigational Site | Savannah | Georgia | 31405 | United States |
| Ferring Investigational Site | Burr Ridge | Illinois | 60527 | United States |
| Ferring Investigational Site | Maywood | Illinois | 60153 | United States |
| Ferring Investigational Site | Iowa City | Iowa | 52242 | United States |
| Ferring Investigational Site | Wichita | Kansas | 67211 | United States |
| Ferring Investigational Site | Jefferson | Louisiana | 70121 | United States |
| Ferring Investigational Site | Boston | Massachusetts | 02115 | United States |
| Ferring Investigational Site | Worcester | Massachusetts | 01608 | United States |
| Ferring Investigational Site | Detroit | Michigan | 48201 | United States |
| Ferring Investigational Site | Detroit | Michigan | 48202 | United States |
| Ferring Investigational Site | Farmington Hills | Michigan | 48336 | United States |
| Ferring Investigational Site | Omaha | Nebraska | 68198 | United States |
| Ferring Investigational Site | Teaneck | New Jersey | 07666 | United States |
| Ferring Investigational Site | New York | New York | 10016 | United States |
| Ferring Investigational Site | New York | New York | 10021 | United States |
| Ferring Investigational Site | New York | New York | 10279 | United States |
| Ferring Investigational Site | Rochester | New York | 14618 | United States |
| Ferring Investigational Site | Stony Brook | New York | 11794 | United States |
| Ferring Investigational Site | Fargo | North Dakota | 58122 | United States |
| Ferring Investigational Site | Cincinnati | Ohio | 45267 | United States |
| Ferring Investigational Site | Middleburg Heights | Ohio | 44130 | United States |
| Ferring Investigational Site | DuBois | Pennsylvania | 15801 | United States |
| Ferring Investigational Site | Pittsburgh | Pennsylvania | 15237 | United States |
| Ferring Investigational Site | Charleston | South Carolina | 29425 | United States |
| Ferring Investigational Site | Knoxville | Tennessee | 37909 | United States |
| Ferring Investigational Site | Dallas | Texas | 75246 | United States |
| Ferring Investigational Site | Houston | Texas | 77030 | United States |
| Ferring Investigational Site | West Jordan | Utah | 84088 | United States |
| Ferring Investigational Site | Charlottesville | Virginia | 22903 | United States |