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Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

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: NCT03244644
Recruitment Status : Active, not recruiting
First Posted : August 9, 2017
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.

Tracking Information
First Submitted Date  ICMJE August 2, 2017
First Posted Date  ICMJE August 9, 2017
Last Update Posted Date February 18, 2020
Actual Study Start Date  ICMJE July 31, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
Official Title  ICMJE 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
Brief Summary This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. 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. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.
Detailed Description 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. 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Clostridium Difficile Infection
Intervention  ICMJE
  • Drug: RBX2660
    RBX2660 is a microbiota suspension administered as an enema
    Other Name: microbiota suspension
  • Drug: Placebo
    Placebo is normal saline solution administered as an enema
    Other Name: saline solution
Study Arms  ICMJE
  • 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
    Intervention: Drug: Placebo
  • Experimental: Group B
    RBX2660 is an enema of a microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
    Intervention: Drug: RBX2660
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 14, 2020)
267
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2017)
270
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ≥ 18 years old.
  2. Medical record documentation of recurrent CDI per the study definition, that includes either: a) at least one recurrence after a primary episode and has completed at least one round of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization within the last year.
  3. A positive stool test for the presence of toxigenic C. difficile within 30 days prior to or on the date of enrollment.
  4. 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 this course of antibiotics]

Exclusion Criteria:

  1. Currently has continued CDI diarrhea despite being on antibiotics prescribed for CDI treatment.
  2. Previous fecal transplant
  3. History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
  4. Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
  5. Compromised immune system (e.g. immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy)
  6. An absolute neutrophil count of <1000 cells/µL during screening.
  7. Pregnant, breastfeeding, or intends to become pregnant during study participation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03244644
Other Study ID Numbers  ICMJE 2017-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rebiotix Inc.
Study Sponsor  ICMJE Rebiotix Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rebiotix Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP