Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea (PUNCH CD)
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.
Recurrent Clostridium Difficile Infection
Biological: RBX2660 (microbiota suspension)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Open-label Clinical Trial Demonstrating the Safety of RBX2660 Microbiota Suspension for the Treatment of Recurrent Clostridium Difficile-associated Diarrhea (CDAD): the PUNCH CD Study|
- Safety [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]Safety will be assessed by evaluating the incidence, severity, and relatedness of serious adverse events through 56 days after the last treatment with RBX2660.
- Long-term Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Serious adverse events will be assessed through 6 months after the last treatment with RBX2660.
- Efficacy [ Time Frame: 56 days ] [ Designated as safety issue: No ]Absence or presence of CDAD at Day 56 after receiving RBX2660. Subjects who reoccur before Day 56 may receive a second treatment with RBX2660 within 10 days of recurrence.
- Quality of Life [ Time Frame: 60 days ] [ Designated as safety issue: No ]Quality of life 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.
- Post-treatment Hospitalization Data [ Time Frame: 6 months ] [ Designated as safety issue: No ]Hospitalization cost, number of ICU days, and length of stay data will be collected for subjects who receive RBX2660 and who are subsequently hospitalized for recurrent CDAD treatment.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Experimental: RBX2660 (microbiota suspension)||Biological: RBX2660 (microbiota suspension)|
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.
|United States, Arizona|
|Mayo Clinic Arizona|
|Phoenix, Arizona, United States, 85054|
|United States, Colorado|
|Denver Health and University of Colorado|
|Denver, Colorado, United States, 80204|
|United States, Florida|
|Jacksonville, Florida, United States, 32216|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Edward Hines Jr VA Hospital (veterans only)|
|Chicago (Hines), Illinois, United States, 60141|
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70121|
|United States, Maryland|
|Chevy Chase Clinical Research|
|Chevy Chase, Maryland, United States, 20815|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|Detroit Medical Center|
|Detroit, Michigan, United States, 48201|
|United States, Minnesota|
|Mayo Clinic - Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|United States, North Dakota|
|Fargo, North Dakota, United States, 58122|