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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 : April 10, 2023
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.

Study Description
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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.

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 817 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Active
RBX2660 is an enema of a microbiota suspension
 Drug: RBX2660
RBX2660 is a microbiota suspension administered as an enema
Other Name: Microbiota suspension


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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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 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.
  3. 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.]

Exclusion Criteria:

  1. Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
  2. Requires systemic antibiotic therapy for a condition other than CDI.
  3. Fecal microbiota transplant (FMT) within the past 6 months.
  4. FMT with an associated serious adverse event related to the FMT product or procedure.
  5. Bezlotoxumab (CDI monoclonal antibodies) if received within the last year.
  6. CD4 count <200/mm^3 during Screening.
  7. An absolute neutrophil count of <1000 cells/µL during Screening.
  8. Pregnant, breastfeeding, or intends to become pregnant during study participation.
Contacts and Locations
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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): NCT03931941


Locations
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Sponsors and Collaborators
Rebiotix Inc.
Investigators
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Study Chair: Teena Chopra, M.D., M.P.H. Wayne State University
More Information
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Responsible Party: Rebiotix Inc.
ClinicalTrials.gov Identifier: NCT03931941    
Other Study ID Numbers: 2019-01
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 10, 2023
Last Verified: April 2023

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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 Diarrhea
Clostridium Difficile
CDI
FMT
Fecal Microbiota Transplant
Microbiota Restoration Therapy
Diarrhea
 Microbial Suspension
Fecal Transplant
C Difficile Colitis
Clostridium Difficile Associated Diarrhea
C diff diarrhea
C Difficile
C diff
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Clostridium Infections
Disease Attributes
 Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses