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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 : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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 : April 2020
Estimated Study Completion Date : April 2020

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




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.



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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) recurrent CDI per the study definition, that includes at least one recurrence after a primary episode and has completed at least one round of standard-of-care oral antibiotic therapy, b) or has had at least two episodes of severe CDI resulting in hospitalization.
  3. A positive stool test for the presence of toxigenic C. difficile or C. difficile toxin 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 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/mm3 during Screening.
  7. An absolute neutrophil count of <1000 cells/µL during Screening.
  8. Pregnant, breastfeeding, or intends to become pregnant during study participation.

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


Contacts
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Contact: Paul Plumb 651-705-8778 studyinfo@Rebiotix.com

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Sponsors and Collaborators
Rebiotix Inc.

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Responsible Party: Rebiotix Inc.
ClinicalTrials.gov Identifier: NCT03931941     History of Changes
Other Study ID Numbers: 2019-01
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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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.:
Fecal Microbiota Transplant
Microbiota Restoration Therapy
Fecal Transplant
C. Difficile Diarrhea
Clostridium Difficile
CDI
FMT
Diarrhea
Microbial Suspension
C Difficile Colitis
Clostridium Difficile Associated Diarrhea
C diff diarrhea
C Difficile
C diff
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections