Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
- Conditions
- InfectionClostridium Difficile InfectionCommunicable Diseases
- Interventions
- Registration Number
- NCT03931941
- Lead Sponsor
- Rebiotix Inc.
- Brief Summary
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.
- Detailed Description
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) safety via assessment of treatment-emergent adverse events and (ii) efficacy of RBX2660 preventing recurrent episodes of CDI measured at 8 weeks after treatment. Follow-up office visits occur at 1 week and 8 weeks after completing the initial study treatment. Telephone assessments occur at 4 weeks, and 4 and 6 months after the study. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 793
- ≥ 18 years old.
- Medical record documentation of either: a) a current diagnosis or history of recurrent CDI as determined by the treating physician, b) or has had at least two episodes of severe CDI resulting in hospitalization.
- Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment. [Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking antibiotics during screening.]
- Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
- Requires systemic antibiotic therapy for a condition other than CDI.
- Fecal microbiota transplant (FMT) within the past 6 months.
- FMT with an associated serious adverse event related to the FMT product or procedure.
- Bezlotoxumab (CDI monoclonal antibodies) if received within the last year.
- CD4 count <200/mm^3 during Screening.
- An absolute neutrophil count of <1000 cells/µL during Screening.
- Pregnant, breastfeeding, or intends to become pregnant during study participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active RBX2660 RBX2660 is an enema of a microbiota suspension
- Primary Outcome Measures
Name Time Method Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI. Up to 6 months after last study treatment. Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).
- Secondary Outcome Measures
Name Time Method Sustained Clinical Response Through 6 Months After Treatment. 6 months after completing the study treatment Treatment success of the presenting CDI recurrence and no new CDI episodes for greater than 8 weeks through 6 months after completing a study treatment assessed by subject phone interview up to 6 months after the last study treatment.
Efficacy of RBX2660 Measured at 8 Weeks After Treatment. 8 weeks after completing the study treatment The absence of C. difficile diarrhea without the need for retreatment through 8 weeks after administration of the study treatment.
Trial Locations
- Locations (50)
Baltimore
🇺🇸Baltimore, Maryland, United States
Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Victoria
🇨🇦Victoria, British Columbia, Canada
Phoenix
🇺🇸Phoenix, Arizona, United States
Durham
🇺🇸Durham, North Carolina, United States
Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Houston
🇺🇸Houston, Texas, United States
Marshfield
🇺🇸Marshfield, Wisconsin, United States
Atlanta
🇺🇸Atlanta, Georgia, United States
Oxnard
🇺🇸Oxnard, California, United States
Burr Ridge
🇺🇸Burr Ridge, Illinois, United States
North Little Rock
🇺🇸North Little Rock, Arkansas, United States
Seattle
🇺🇸Seattle, Washington, United States
Madison
🇺🇸Madison, Wisconsin, United States
Fargo
🇺🇸Fargo, North Dakota, United States
Plymouth
🇺🇸Plymouth, Minnesota, United States
St. Louis
🇺🇸Saint Louis, Missouri, United States
New York
🇺🇸New York, New York, United States
Wichita
🇺🇸Wichita, Kansas, United States
Detroit
🇺🇸Detroit, Michigan, United States
Dallas
🇺🇸Dallas, Texas, United States
Spokane
🇺🇸Spokane, Washington, United States
Annandale
🇺🇸Annandale, Virginia, United States
Nashville
🇺🇸Nashville, Tennessee, United States
Springfield
🇺🇸Springfield, Virginia, United States
Hixon
🇺🇸Hixon, Tennessee, United States
Vancouver
🇨🇦Vancouver, British Columbia, Canada
Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
Aurora
🇺🇸Aurora, Colorado, United States
Hamden
🇺🇸Hamden, Connecticut, United States
Decatur
🇺🇸Decatur, Georgia, United States
Idaho Falls
🇺🇸Idaho Falls, Idaho, United States
Jacksonville
🇺🇸Jacksonville, Florida, United States
Naples
🇺🇸Naples, Florida, United States
Shreveport
🇺🇸Shreveport, Louisiana, United States
Gurnee
🇺🇸Gurnee, Illinois, United States
Fort Wayne
🇺🇸Fort Wayne, Indiana, United States
Rochester
🇺🇸Rochester, New York, United States
Cleveland
🇺🇸Cleveland, Ohio, United States
Wyomissing
🇺🇸Wyomissing, Pennsylvania, United States
West Jordan
🇺🇸West Jordan, Utah, United States
Edmonton
🇨🇦Edmonton, Alberta, Canada
Calgary
🇨🇦Calgary, Alberta, Canada
Moncton
🇨🇦Moncton, New Brunswick, Canada
Orlando
🇺🇸Orlando, Florida, United States
Gainesville
🇺🇸Gainesville, Florida, United States
New Orleans
🇺🇸New Orleans, Louisiana, United States
Charleston
🇺🇸Charleston, South Carolina, United States
Port Orange
🇺🇸Port Orange, Florida, United States
Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States