Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
NCT ID: NCT03244644
Last Updated: 2024-07-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
320 participants
INTERVENTIONAL
2017-07-31
2020-08-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo is an suspension of normal saline. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding
Placebo
Placebo is normal saline solution administered rectally
Open label RBX2660 (only for confirmed CDI recurrence)
RBX2660 administered as a second treatment after confirmed CDI recurrence following the initial dose of placebo or RBX2660
RBX2660
RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation United States Pharmacopeia (USP) solution and cryoprotectant
RBX2660
RBX2660 is a rectally administered microbiota suspension
Open label RBX2660 (only for confirmed CDI recurrence)
RBX2660 administered as a second treatment after confirmed CDI recurrence following the initial dose of placebo or RBX2660
Interventions
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RBX2660
RBX2660 is a rectally administered microbiota suspension
Placebo
Placebo is normal saline solution administered rectally
Open label RBX2660 (only for confirmed CDI recurrence)
RBX2660 administered as a second treatment after confirmed CDI recurrence following the initial dose of placebo or RBX2660
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Medical record documentation of recurrent CDI per the study definition, that includes either: a) at least one recurrence after a primary episode and has completed at least one round of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization within the last year.
3. A positive stool test for the presence of toxigenic C. difficile 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.
\[Note: Subject's CDI diarrhea must be controlled (\<3 unformed/loose stools/day) while taking this course of antibiotics\]
Exclusion Criteria
2. Previous fecal transplant
3. History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, 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 or medication; 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.
18 Years
ALL
No
Sponsors
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Rebiotix Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teena Chopra, M.D., M.P.H.
Role: STUDY_CHAIR
Wayne State University
Locations
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Athens
Athens, Alabama, United States
Dothan
Dothan, Alabama, United States
Phoenix
Phoenix, Arizona, United States
North Little Rock
North Little Rock, Arkansas, United States
Lancaster
Lancaster, California, United States
Los Angeles
Los Angeles, California, United States
Oxnard
Oxnard, California, United States
Sacramento
Sacramento, California, United States
Aurora
Aurora, Colorado, United States
Hamden
Hamden, Connecticut, United States
Gainesville
Gainesville, Florida, United States
Jacksonville
Jacksonville, Florida, United States
Miami
Miami, Florida, United States
Port Orange
Port Orange, Florida, United States
Atlanta
Atlanta, Georgia, United States
Atlanta
Atlanta, Georgia, United States
Idaho Falls
Idaho Falls, Idaho, United States
Gurnee
Gurnee, Illinois, United States
Highland Park
Highland Park, Illinois, United States
Maywood
Maywood, Illinois, United States
Lafayette
Lafayette, Indiana, United States
Topeka
Topeka, Kansas, United States
Wichita
Wichita, Kansas, United States
Lexington
Lexington, Kentucky, United States
New Orleans
New Orleans, Louisiana, United States
Shreveport
Shreveport, Louisiana, United States
Boston
Boston, Massachusetts, United States
Detroit
Detroit, Michigan, United States
Plymouth
Plymouth, Minnesota, United States
Rochester
Rochester, Minnesota, United States
St. Louis
St Louis, Missouri, United States
Omaha
Omaha, Nebraska, United States
Omaha
Omaha, Nebraska, United States
Las Vegas
Las Vegas, Nevada, United States
Teaneck
Teaneck, New Jersey, United States
New York
New York, New York, United States
North Massapequa
North Massapequa, New York, United States
Rochester
Rochester, New York, United States
Durham
Durham, North Carolina, United States
Greenville
Greenville, North Carolina, United States
Wilmington
Wilmington, North Carolina, United States
Fargo
Fargo, North Dakota, United States
Toledo
Toledo, Ohio, United States
Portland
Portland, Oregon, United States
Flourtown
Flourtown, Pennsylvania, United States
Philadelphia
Philadelphia, Pennsylvania, United States
Philadelphia
Philadelphia, Pennsylvania, United States
Uniontown
Uniontown, Pennsylvania, United States
Wyomissing
Wyomissing, Pennsylvania, United States
Charleston
Charleston, South Carolina, United States
Rapid City
Rapid City, South Dakota, United States
Hixson
Hixson, Tennessee, United States
Dallas
Dallas, Texas, United States
Houston
Houston, Texas, United States
West Jordan
West Jordan, Utah, United States
Springfield
Springfield, Virginia, United States
Winchester
Winchester, Virginia, United States
Seattle
Seattle, Washington, United States
Madison
Madison, Wisconsin, United States
Marshfield
Marshfield, Wisconsin, United States
Calgary
Calgary, Alberta, Canada
Edmonton
Edmonton, Alberta, Canada
Vancouver
Vancouver, British Columba, Canada
Victoria
Victoria, British Columbia, Canada
Fredericton
Fredericton, New Brunswick, Canada
Moncton
Moncton, New Brunswick, Canada
Countries
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References
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Bakken JS. Feces transplantation for recurrent Clostridium difficile infection: US experience and recommendations. Microb Ecol Health Dis. 2015 May 29;26:27657. doi: 10.3402/mehd.v26.27657. eCollection 2015. No abstract available.
EISEMAN B, SILEN W, BASCOM GS, KAUVAR AJ. Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis. Surgery. 1958 Nov;44(5):854-9. No abstract available.
Miller MA, Louie T, Mullane K, Weiss K, Lentnek A, Golan Y, Kean Y, Sears P. Derivation and validation of a simple clinical bedside score (ATLAS) for Clostridium difficile infection which predicts response to therapy. BMC Infect Dis. 2013 Mar 25;13:148. doi: 10.1186/1471-2334-13-148.
Mishra R, Harvey A, Guo A, Tillotson G, Feuerstadt P, Khanna S, Shannon WD, Blount KF. Microbiome and metabolome changes after fecal microbiota, live-jslm, administration are associated with health-related quality of life improvements. Anaerobe. 2025 Oct 18:103006. doi: 10.1016/j.anaerobe.2025.103006. Online ahead of print.
Adamowicz E, Kraft CS, Ward T, Mehta N, Shannon WD, Mishra R, Blount KF. Decreased Antimicrobial Resistance Gene Richness Following Fecal Microbiota, Live-jslm (REBYOTA(R)) Administration: Post Hoc Analysis of PUNCH CD3. Open Forum Infect Dis. 2025 Jul 2;12(7):ofaf382. doi: 10.1093/ofid/ofaf382. eCollection 2025 Jul.
Claypool J, Lindved G, Myers PN, Ward T, Nielsen HB, Blount KF. Microbiome compositional changes and clonal engraftment in a phase 3 trial of fecal microbiota, live-jslm for recurrent Clostridioides difficile infection. Gut Microbes. 2025 Dec;17(1):2520412. doi: 10.1080/19490976.2025.2520412. Epub 2025 Jun 24.
Blount KF, Papazyan R, Ferdyan N, Srinivasan K, Gonzalez C, Shannon WD, Fuchs BC. Microbiome and Metabolome Restoration After Administration of Fecal Microbiota, Live-jslm (REBYOTA) for Preventing Recurrent Clostridioides difficile Infection. J Infect Dis. 2025 Jul 11;231(6):e1022-e1033. doi: 10.1093/infdis/jiae418.
Feuerstadt P, Allegretti JR, Dubberke ER, Guo A, Harvey A, Yang M, Garcia-Horton V, Fillbrunn M, Tillotson G, Bancke LL, LaPlante K, Garey KW, Khanna S. Efficacy and Health-Related Quality of Life Impact of Fecal Microbiota, Live-jslm: A Post Hoc Analysis of PUNCH CD3 Patients at First Recurrence of Clostridioides difficile Infection. Infect Dis Ther. 2024 Jan;13(1):221-236. doi: 10.1007/s40121-023-00907-w. Epub 2024 Jan 18.
Garey KW, Dubberke ER, Guo A, Harvey A, Yang M, Garcia-Horton V, Fillbrunn M, Wang H, Tillotson GS, Bancke LL, Feuerstadt P. Effect of Fecal Microbiota, Live-Jslm (REBYOTA [RBL]) on Health-Related Quality of Life in Patients With Recurrent Clostridioides difficile Infection: Results From the PUNCH CD3 Clinical Trial. Open Forum Infect Dis. 2023 Jul 20;10(8):ofad383. doi: 10.1093/ofid/ofad383. eCollection 2023 Aug.
Khanna S, Assi M, Lee C, Yoho D, Louie T, Knapple W, Aguilar H, Garcia-Diaz J, Wang GP, Berry SM, Marion J, Su X, Braun T, Bancke L, Feuerstadt P. Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection. Drugs. 2022 Oct;82(15):1527-1538. doi: 10.1007/s40265-022-01797-x. Epub 2022 Oct 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Centers for Disease Control page last reviewed March 15, 2021; accessed March 01, 2022.
Sponsor website
Other Identifiers
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2017-01
Identifier Type: -
Identifier Source: org_study_id
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