Clostridium Difficile Infection Recurrence
Conditions
Keywords
C. Difficile Diarrhea, Clostridium Difficile, CDI, FMT, Fecal Microbiota Transplant, Microbiota Restoration Therapy, Diarrhea, Microbial Suspension, Fecal Transplant, C Difficile Colitis, Clostridium Difficile Associated Diarrhea, C diff diarrhea, C Difficile, C diff
Brief summary
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy. More specifically, the purpose of this trial is to explore the safety and clinical effectiveness of RBX2660 when delivered by colonoscopy to adults with rCDI. The experience of physicians will be documented through a physician-experience questionnaire to explore the usability of RBX2660 in clinical practice for colonoscopic administration. Furthermore, to explore the patient-experience of RBX2660 treatment, each trial participant will be offered to undergo a structured interview.
Interventions
DRUGRBX2660
RBX2660 should be administered to the right side of the colon (i.e., between the ileocecal valve and the hepatic flexure of the colon).
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* have documented evidence of rCDI (≥1 recurrence after a primary CDI episode) * be undergoing antibiotic treatment for the qualifying rCDI episode that was diagnosed by a stool test for the presence of toxigenic C. difficile or C. difficile toxin * be eligible for FMT as judged by the investigator or current treatment guidelines for rCDI in the US * be a candidate for colonoscopy as judged by the investigator
Exclusion criteria
* Use or planned use of systemic antibiotics for an indication other than the qualifying rCDI episode. * Current uncontrolled chronic diarrhea not related to CDI. * Receipt of CDI vaccine or treatment with CDI monoclonal antibodies within the past 12 months before screening. * Evidence of active, severe, or fulminant colitis, diagnosis of toxic megacolon or have a current colostomy or ileostomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With RBX2660-related Treatment-emergent Adverse Events (TEAEs) After RBX2660 Treatment Delivered by Colonoscopy Through 8 Weeks, or Treatment Failure | 8 weeks after RBX2660 treatment delivered by colonoscopy |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Recurrence of Clostridioides Difficile Infection (CDI) Within 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy. | Within 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Time to CDI Recurrence From Baseline Through 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy | 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Physician-experience, as Determined by Questionnaire, Documenting Subjective Experience of Investigators on Usability of RBX2660 in Clinical Practice When Delivered by Colonoscopy | At Day 1 (baseline visit) |
| Physician Perception of Patient Benefit, as Determined by Number of Participants With Clinician Global Impression of Improvement (CGI-I) at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy | 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Patient-experience Interview at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy | 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Number of Participants With Treatment-emergent Adverse Events up to 8 Weeks or Treatment Failure After RBX2660 Treatment | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Number of Participants With Serious Adverse Events (SAEs) | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Number of Participants With Any Adverse Events of Special Interest (AESIs) | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy |
| Number of Participants With Adverse Events Leading to Death or Intensive Care Unit (ICU) Admission | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy |
Countries
United States
Contacts
STUDY_DIRECTORGlobal Clinical Compliance
Ferring Pharmaceuticals
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.2 Years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of Previous CDI Episodes | 3.2 Episodes STANDARD_DEVIATION 1.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 6 / 41 |
| serious Total, serious adverse events | 2 / 41 |
Outcome results
None listed