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Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS) (CD3-OLS)

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ClinicalTrials.gov Identifier: NCT03931941
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.

Tracking Information
First Submitted Date  ICMJE April 26, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date April 15, 2021
Actual Study Start Date  ICMJE July 30, 2019
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • 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.
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 (PUNCH CD3-OLS)
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Clostridium Difficile Infection
  • Infection
  • Communicable Diseases
Intervention  ICMJE Drug: RBX2660
RBX2660 is a microbiota suspension administered as an enema
Other Name: Microbiota suspension
Study Arms  ICMJE Experimental: Active
RBX2660 is an enema of a microbiota suspension
Intervention: Drug: RBX2660
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 17, 2020)
500
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2019)
200
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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: Paul Plumb 651-705-8778 US8-StudyInfo@ferring.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931941
Other Study ID Numbers  ICMJE 2019-01
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 April 2021

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