Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
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|ClinicalTrials.gov Identifier: NCT03244644|
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : August 3, 2022
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Drug: RBX2660 Drug: Placebo||Phase 3|
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI and (ii) safety via assessment of adverse events. The primary efficacy analysis of the study will be a Bayesian hierarchical model, which formally incorporates data from a previous randomized Phase 2b study (Protocol 2014-01) of RBX2660.
Follow-up office visits occur at weeks 1-, 4- and 8 after completing the blinded study treatment. Telephone assessments for adverse events occur during weeks 2, 3 and 6 after the study enema and at months 3 and 6. Patients who have had at least one recurrence 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 within the last year may be eligible for the study. Study Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||267 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection|
|Actual Study Start Date :||July 31, 2017|
|Actual Primary Completion Date :||April 2, 2020|
|Actual Study Completion Date :||August 3, 2020|
Placebo Comparator: Group A
Placebo is an enema of normal saline. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding
Placebo is normal saline solution administered as an enema
Other Name: saline solution
Experimental: Group B
RBX2660 is an enema of a microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
RBX2660 is a microbiota suspension administered as an enema
Other Name: microbiota suspension
- Efficacy of RBX2660 compared to Placebo measured at 8 weeks [ Time Frame: 1, 4, and 8 weeks after completing the study treatment ]The absence of C. difficile diarrhea without the need for retreatment as assessed by subject interview and physical exam 1, 4, and 8 weeks after administration of the study treatment.
- Number of subjects with adverse events through 6 months [ Time Frame: Up to 6 months after completing the study treatment ]Documented adverse events will be categorized by frequency, severity, seriousness, and causality as assessed by subject interview and physical exam at 1-week, 4-week, and 8-week visits, and by subject phone interviews at 3 and 6 months from the last study treatment received.
- Health Related Quality of Life (HRQOL) Assessment [ Time Frame: Up to 6 months after completing the study treatment ]Screening HRQOL scores will be compared to scores obtained at the 1-Week, 4-week, and 8-week assessment visits, and 3 and 6 month phone assessments
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): NCT03244644
|Study Chair:||Teena Chopra, M.D., M.P.H.||Wayne State University|