Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

Last updated: July 8, 2024
Sponsor: Rebiotix Inc.
Overall Status: Completed

Phase

3

Condition

Gastroenteritis

Clostridium Difficile-associated Diarrhea

Treatment

RBX2660

Open label RBX2660 (only for confirmed CDI recurrence)

Placebo

Clinical Study ID

NCT03244644
2017-01
  • Ages > 18
  • All Genders

Study Summary

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence 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 Clostridioides difficile infection (CDI) resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded dose of RBX2660.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥ 18 years old.

  2. Medical record documentation of recurrent CDI per the study definition, thatincludes either: a) at least one recurrence after a primary episode and hascompleted at least one round of standard-of-care oral antibiotic therapy or b) hashad at least two episodes of severe CDI resulting in hospitalization within the lastyear.

  3. A positive stool test for the presence of toxigenic C. difficile within 30 daysprior to or on the date of enrollment.

  4. 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 this course of antibiotics]

Exclusion

Exclusion Criteria:

  1. Currently has continued CDI diarrhea despite being on antibiotics prescribed for CDItreatment.

  2. Previous fecal transplant

  3. History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn'sdisease, or microscopic colitis.

  4. Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.

  5. Compromised immune system (e.g. immunosuppressed due to a medical condition ormedication; current or recent (< 90 days) treatment with chemotherapy)

  6. An absolute neutrophil count of <1000 cells/µL during screening.

  7. Pregnant, breastfeeding, or intends to become pregnant during study participation.

Study Design

Total Participants: 320
Treatment Group(s): 3
Primary Treatment: RBX2660
Phase: 3
Study Start date:
July 31, 2017
Estimated Completion Date:
August 03, 2020

Study Description

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI and (ii) safety via assessment of adverse events. The primary efficacy analysis of the study will be a Bayesian hierarchical model, which formally incorporates data from a previous randomized Phase 2b study (Protocol 2014-01, NCT02299570) of RBX2660.

Follow-up office visits occur at weeks 1-, 4- and 8 after completing the blinded study treatment. Telephone assessments for adverse events occur during weeks 2, 3 and 6 after the study treatment and at months 3 and 6. Patients who have had at least one recurrence 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 within the last year may be eligible for the study. Study Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded dose of RBX2660.

Connect with a study center

  • Calgary

    Calgary, Alberta T2N2T9
    Canada

    Site Not Available

  • Edmonton

    Edmonton, Alberta TG2X8
    Canada

    Site Not Available

  • Vancouver

    Vancouver, British Columba V5Z1M9
    Canada

    Site Not Available

  • Victoria

    Victoria, British Columbia BC V8R 1J8
    Canada

    Site Not Available

  • Fredericton

    Fredericton, New Brunswick E3B 4R3
    Canada

    Site Not Available

  • Moncton

    Moncton, New Brunswick E1C628
    Canada

    Site Not Available

  • Athens

    Athens, Alabama 35611
    United States

    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 33176
    United States

    Site Not Available

  • Port Orange

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Atlanta

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Idaho Falls

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Gurnee

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Highland Park

    Highland Park, Illinois 60035
    United States

    Site Not Available

  • Maywood

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Lafayette

    Lafayette, Indiana 47904
    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
    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

  • 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

  • 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

  • Rochester

    Rochester, New York 14618
    United States

    Site Not Available

  • Durham

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Greenville

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Wilmington

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Fargo

    Fargo, North Dakota 58102
    United States

    Site Not Available

  • Lima

    Lima, Ohio 45801
    United States

    Site Not Available

  • Toledo

    Toledo, Ohio 43608
    United States

    Site Not Available

  • Portland

    Portland, Oregon 97701
    United States

    Site Not Available

  • Flourtown

    Flourtown, Pennsylvania 19031
    United States

    Site Not Available

  • Philadelphia

    Philadelphia, Pennsylvania 19102
    United States

    Site Not Available

  • Uniontown

    Uniontown, Pennsylvania 15401
    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

  • Hixson

    Hixson, Tennessee 37434
    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

  • 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

  • Madison

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Marshfield

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

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