This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.
This is the first study of a microbiota suspension derived from intestinal microbes. The primary assessments for this open label, multi-center study are (i) occurrence of product-related adverse events and (ii) resolution of CDAD at 56 days after administration of RBX2660. Subjects will also be assessed for time to CDAD recurrence, quality of life changes, and number of hospitalizations and length of stay for recurrent CDAD. Study visits will be at 7, 30, and 60 days after RBX2660 administration with additional follow-up at 3 and 6 months post treatment. Patients who have had at least two recurrences of CDAD after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDAD resulting in hospitalization may be eligible for the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Mayo Clinic Arizona
Phoenix, Arizona, United States
Denver Health and University of Colorado
Denver, Colorado, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660
Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.
Time frame: 56 days
Long-term Safety
The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.
Time frame: 6 months
Absence of CDAD at 56 Days
Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.
Time frame: 56 days
Quality of Life (SF-36)
Quality of Life (SF-36) will be assessed by comparing the subject's baseline quality of life score to his/her scores obtained at the 7-, 30- and 60-day follow-up visits. The scale is from 0-100, with higher scores meaning better outcomes.
Time frame: 60 days
Post-treatment Hospitalization Data
number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.
Time frame: 6 months
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Edward Hines Jr VA Hospital (veterans only)
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Detroit Medical Center
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
...and 3 more locations