We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03244644
Previous Study | Return to List | Next Study

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 : Completed
First Posted : August 9, 2017
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: RBX2660 Drug: Placebo Phase 3

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. 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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 Drug: Placebo
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
 Drug: RBX2660
RBX2660 is a microbiota suspension administered as an enema
Other Name: microbiota suspension


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Show Show 66 study locations
Sponsors and Collaborators
Rebiotix Inc.
Investigators
Layout table for investigator information
Study Chair: Teena Chopra, M.D., M.P.H. Wayne State University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Rebiotix Inc.
ClinicalTrials.gov Identifier: NCT03244644    
Other Study ID Numbers: 2017-01
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: March 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebiotix Inc.:
C Difficile Colitis
Clostridium Difficile
CDI
C.Difficile Diarrhea
Fecal Transplant
 Fecal Microbiota Transplant
Microbiota Restoration Therapy
Diarrhea
FMT
Microbial Suspension
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Clostridium Infections
Disease Attributes
 Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses