Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS) (CD3-OLS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03931941|
Recruitment Status : Active, not recruiting
First Posted : April 30, 2019
Last Update Posted : January 12, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection Infection Communicable Diseases||Drug: RBX2660||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||816 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (Microbiota Suspension) in Subjects With Recurrent Clostridium Difficile Infection|
|Actual Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
RBX2660 is an enema of a microbiota suspension
RBX2660 is a microbiota suspension administered as an enema
Other Name: Microbiota suspension
- Safety and tolerability of RBX2660 in subjects with recurrent CDI. [ Time Frame: Up to 6 months after last study treatment. ]Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).
- Efficacy of RBX2660 measured at 8 weeks after treatment. [ Time Frame: 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.
- Sustained clinical response through 6 months after treatment. [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- ≥ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931941
|Study Chair:||Teena Chopra, M.D., M.P.H.||Wayne State University|
|Responsible Party:||Rebiotix Inc.|
|Other Study ID Numbers:||
|First Posted:||April 30, 2019 Key Record Dates|
|Last Update Posted:||January 12, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
C. Difficile Diarrhea
Fecal Microbiota Transplant
Microbiota Restoration Therapy
C Difficile Colitis
Clostridium Difficile Associated Diarrhea
C diff diarrhea
Gram-Positive Bacterial Infections
Bacterial Infections and Mycoses