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

Last updated: July 12, 2024
Sponsor: Rebiotix Inc.
Overall Status: Completed

Phase

3

Condition

Clostridium Difficile-associated Diarrhea

Gastroenteritis

Treatment

RBX2660

Clinical Study ID

NCT03931941
2019-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥ 18 years old.

  2. Medical record documentation of either: a) a current diagnosis or history ofrecurrent CDI as determined by the treating physician, b) or has had at least twoepisodes of severe CDI resulting in hospitalization.

  3. Is currently taking or was just prescribed antibiotics to control CDI relateddiarrhea at the time of enrollment. [Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking antibiotics during screening.]

Exclusion

Exclusion Criteria:

  1. Has continued CDI diarrhea despite being on a course of antibiotics prescribed forCDI 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 orprocedure.

  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.

Study Design

Total Participants: 793
Treatment Group(s): 1
Primary Treatment: RBX2660
Phase: 3
Study Start date:
July 30, 2019
Estimated Completion Date:
July 21, 2023

Study 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.

Connect with a study center

  • Calgary

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Edmonton

    Edmonton, Alberta T6G 2X8
    Canada

    Site Not Available

  • Vancouver

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Victoria

    Victoria, British Columbia V8R 1J8
    Canada

    Site Not Available

  • Moncton

    Moncton, New Brunswick E1C 6Z8
    Canada

    Site Not Available

  • Dothan

    Dothan, Alabama 36305
    United States

    Site Not Available

  • Phoenix

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • North Little Rock

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • Lancaster

    Lancaster, California 93534
    United States

    Site Not Available

  • Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • Oxnard

    Oxnard, California 93030
    United States

    Site Not Available

  • Sacramento

    Sacramento, California 95817
    United States

    Site Not Available

  • Aurora

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Hamden

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • Gainesville

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Naples

    Naples, Florida 34102
    United States

    Site Not Available

  • Orlando

    Orlando, Florida 32806
    United States

    Site Not Available

  • Port Orange

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Atlanta

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Decatur

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Idaho Falls

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Burr Ridge

    Burr Ridge, Illinois 60527
    United States

    Site Not Available

  • Gurnee

    Gurnee, Illinois 60035
    United States

    Site Not Available

  • Highland Park

    Highland Park, Illinois 60035
    United States

    Site Not Available

  • Fort Wayne

    Fort Wayne, Indiana 46845
    United States

    Site Not Available

  • Topeka

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Lexington

    Lexington, Kentucky 40536-0298
    United States

    Site Not Available

  • New Orleans

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Shreveport

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Baltimore

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Detroit

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Plymouth

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Omaha

    Omaha, Nebraska 68198-4031
    United States

    Site Not Available

  • Las Vegas

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Teaneck

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • New York

    New York, New York 10016
    United States

    Site Not Available

  • North Massapequa

    North Massapequa, New York 11758
    United States

    Site Not Available

  • Durham

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Fargo

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • Cleveland

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Oklahoma City

    Oklahoma City, Oklahoma 73102
    United States

    Site Not Available

  • Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Wyomissing

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Charleston

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Rapid City

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Hixon

    Hixon, Tennessee 37434
    United States

    Site Not Available

  • Nashville

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Austin

    Austin, Texas 78613
    United States

    Site Not Available

  • Dallas

    Dallas, Texas 75246
    United States

    Site Not Available

  • Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • West Jordan

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Annandale

    Annandale, Virginia 22003
    United States

    Site Not Available

  • Springfield

    Springfield, Virginia 22150
    United States

    Site Not Available

  • Winchester

    Winchester, Virginia 22601
    United States

    Site Not Available

  • Seattle

    Seattle, Washington 98104
    United States

    Site Not Available

  • Spokane

    Spokane, Washington 99202
    United States

    Site Not Available

  • Madison

    Madison, Wisconsin 53704
    United States

    Site Not Available

  • Marshfield

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Milwaukee

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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