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

Sponsor
Rebiotix Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03931941
Collaborator
(none)
600
Enrollment
60
Locations
1
Arm
40.1
Anticipated Duration (Months)
10
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated Enrollment :
600 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 :
Jul 30, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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 Names:
  • Microbiota suspension

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability of RBX2660 in subjects with recurrent CDI. [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. [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. [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Phoenix Phoenix Arizona United States 85054
    2 North Little Rock North Little Rock Arkansas United States 72117
    3 Lancaster Lancaster California United States 93534
    4 Los Angeles Los Angeles California United States 90048
    5 Los Angeles Los Angeles California United States 90095
    6 Oxnard Oxnard California United States 93030
    7 Sacramento Sacramento California United States 95817
    8 Aurora Aurora Colorado United States 80045
    9 Hamden Hamden Connecticut United States 06518
    10 Gainesville Gainesville Florida United States 32610
    11 Jacksonville Jacksonville Florida United States 32224
    12 Miami Miami Florida United States 33136
    13 Naples Naples Florida United States 34102
    14 Orlando Orlando Florida United States 32806
    15 Port Orange Port Orange Florida United States 32127
    16 Atlanta Atlanta Georgia United States 30309
    17 Decatur Decatur Georgia United States 30033
    18 Idaho Falls Idaho Falls Idaho United States 83404
    19 Burr Ridge Burr Ridge Illinois United States 60527
    20 Gurnee Gurnee Illinois United States 60035
    21 Fort Wayne Fort Wayne Indiana United States 46845
    22 Wichita Wichita Kansas United States 67214
    23 New Orleans New Orleans Louisiana United States 70121
    24 Shreveport Shreveport Louisiana United States 71105
    25 Baltimore Baltimore Maryland United States 21215
    26 Boston Boston Massachusetts United States 02114
    27 Detroit Detroit Michigan United States 48202
    28 Plymouth Plymouth Minnesota United States 55446
    29 Rochester Rochester Minnesota United States 55905
    30 St. Louis Saint Louis Missouri United States 63110
    31 Las Vegas Las Vegas Nevada United States 89106
    32 New York New York New York United States 10016
    33 Rochester Rochester New York United States 14618
    34 Durham Durham North Carolina United States 27710
    35 Fargo Fargo North Dakota United States 58122
    36 Cleveland Cleveland Ohio United States 44195
    37 Oklahoma City Oklahoma City Oklahoma United States 73102
    38 Philadelphia Philadelphia Pennsylvania United States 19107
    39 Pittsburgh Pittsburgh Pennsylvania United States 15213
    40 Wyomissing Wyomissing Pennsylvania United States 19610
    41 Charleston Charleston South Carolina United States 29425
    42 Hixon Hixon Tennessee United States 37434
    43 Nashville Nashville Tennessee United States 37212
    44 Austin Austin Texas United States 78613
    45 Dallas Dallas Texas United States 75246
    46 Houston Houston Texas United States 77030
    47 West Jordan West Jordan Utah United States 84088
    48 Annandale Annandale Virginia United States 22003
    49 Springfield Springfield Virginia United States 22150
    50 Winchester Winchester Virginia United States 22601
    51 Seattle Seattle Washington United States 98104
    52 Spokane Spokane Washington United States 99202
    53 Madison Madison Wisconsin United States 53704
    54 Marshfield Marshfield Wisconsin United States 54449
    55 Milwaukee Milwaukee Wisconsin United States 53215
    56 Calgary Calgary Alberta Canada T2N 2T9
    57 Edmonton Edmonton Alberta Canada T6G 2X8
    58 Vancouver Vancouver British Columbia Canada V5Z 1M9
    59 Victoria Victoria British Columbia Canada V8R 1J8
    60 Moncton Moncton New Brunswick Canada E1C 6Z8

    Sponsors and Collaborators

    • Rebiotix Inc.

    Investigators

    • Study Chair: Teena Chopra, M.D., M.P.H., Wayne State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rebiotix Inc.
    ClinicalTrials.gov Identifier:
    NCT03931941
    Other Study ID Numbers:
    • 2019-01
    First Posted:
    Apr 30, 2019
    Last Update Posted:
    May 31, 2022
    Last Verified:
    Apr 1, 2022
    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:
    Infections
    Communicable Diseases
    Clostridium Infections

    Study Results

    No Results Posted as of May 31, 2022