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

NCT03931941 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 2019-01
• Study Type: interventional
• Target: 793
• Locations: 2 countries
• Sites: 51

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.

Conditions

Clostridium Difficile Infection; Infection; Communicable Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI.

  Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).

  Up to 6 months after last study treatment.

Secondary Outcomes (2)

• Efficacy of RBX2660 Measured at 8 Weeks After Treatment.

  8 weeks after completing the study treatment

• Sustained Clinical Response Through 6 Months After Treatment.

  6 months after completing the study treatment

Study Arms (1)

Active

EXPERIMENTAL

RBX2660 is an enema of a microbiota suspension

Drug: RBX2660

Interventions

RBX2660 DRUG

RBX2660 is a microbiota suspension administered as an enema

Also known as: Microbiota suspension

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old.
• 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.
• Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment. \[Note: Subject's CDI diarrhea must be controlled (\<3 unformed/loose stools/day) while taking antibiotics during screening.\]

You may not qualify if:

• Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
• Requires systemic antibiotic therapy for a condition other than CDI.
• Fecal microbiota transplant (FMT) within the past 6 months.
• FMT with an associated serious adverse event related to the FMT product or procedure.
• Bezlotoxumab (CDI monoclonal antibodies) if received within the last year.
• CD4 count \<200/mm\^3 during Screening.
• An absolute neutrophil count of \<1000 cells/µL during Screening.
• Pregnant, breastfeeding, or intends to become pregnant during study participation.

Sponsors & Collaborators

• Rebiotix Inc.: lead

Study Sites (51)

Phoenix

Phoenix, Arizona, 85054, United States

Location

North Little Rock

North Little Rock, Arkansas, 72117, United States

Location

Oxnard

Oxnard, California, 93030, United States

Location

Aurora

Aurora, Colorado, 80045, United States

Location

Hamden

Hamden, Connecticut, 06518, United States

Location

Gainesville

Gainesville, Florida, 32610, United States

Location

Jacksonville

Jacksonville, Florida, 32224, United States

Location

Naples

Naples, Florida, 34102, United States

Location

Orlando

Orlando, Florida, 32806, United States

Location

Port Orange

Port Orange, Florida, 32127, United States

Location

Atlanta

Atlanta, Georgia, 30309, United States

Location

Decatur

Decatur, Georgia, 30033, United States

Location

Idaho Falls

Idaho Falls, Idaho, 83404, United States

Location

Burr Ridge

Burr Ridge, Illinois, 60527, United States

Location

Gurnee

Gurnee, Illinois, 60035, United States

Location

Fort Wayne

Fort Wayne, Indiana, 46845, United States

Location

Wichita

Wichita, Kansas, 67214, United States

Location

New Orleans

New Orleans, Louisiana, 70121, United States

Location

Shreveport

Shreveport, Louisiana, 71105, United States

Location

Baltimore

Baltimore, Maryland, 21215, United States

Location

Detroit

Detroit, Michigan, 48202, United States

Location

Plymouth

Plymouth, Minnesota, 55446, United States

Location

Rochester

Rochester, Minnesota, 55905, United States

Location

St. Louis

St Louis, Missouri, 63110, United States

Location

New York

New York, New York, 10016, United States

Location

Rochester

Rochester, New York, 14618, United States

Location

Durham

Durham, North Carolina, 27710, United States

Location

Fargo

Fargo, North Dakota, 58122, United States

Location

Cleveland

Cleveland, Ohio, 44195, United States

Location

Oklahoma City

Oklahoma City, Oklahoma, 73102, United States

Location

Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Wyomissing

Wyomissing, Pennsylvania, 19610, United States

Location

Charleston

Charleston, South Carolina, 29425, United States

Location

Hixon

Hixon, Tennessee, 37434, United States

Location

Nashville

Nashville, Tennessee, 37212, United States

Location

Dallas

Dallas, Texas, 75246, United States

Location

Houston

Houston, Texas, 77030, United States

Location

West Jordan

West Jordan, Utah, 84088, United States

Location

Annandale

Annandale, Virginia, 22003, United States

Location

Springfield

Springfield, Virginia, 22150, United States

Location

Seattle

Seattle, Washington, 98104, United States

Location

Spokane

Spokane, Washington, 99202, United States

Location

Madison

Madison, Wisconsin, 53704, United States

Location

Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Milwaukee

Milwaukee, Wisconsin, 53215, United States

Location

Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Edmonton

Edmonton, Alberta, T6G 2X8, Canada

Location

Vancouver

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Victoria

Victoria, British Columbia, V8R 1J8, Canada

Location

Moncton

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Related Publications (4)

• Lee C, Feuerstadt P, Louie T, Bancke L, Guthmueller B, Harvey A, Hoeyer F, Orenstein R, Dubberke ER, Khanna S. Integrated analysis of the safety of fecal microbiota, live-jslm in adults with recurrent Clostridioides difficile infection from five prospective clinical trials: an update. Therap Adv Gastroenterol. 2025 Nov 12;18:17562848251395566. doi: 10.1177/17562848251395566. eCollection 2025.

  PMID: 41245385 DERIVED

• Aroniadis OC, Guthmueller B, Dehlin K, Srivastava S, Feuerstadt P, Lembo A, Weber HC. Safety and Efficacy of Fecal Microbiota, Live-jslm to Prevent Recurrent Clostridioides difficile Infection in Participants With Irritable Bowel Syndrome. Infect Dis Ther. 2025 Sep;14(9):2157-2169. doi: 10.1007/s40121-025-01208-0. Epub 2025 Aug 10.

  PMID: 40784972 DERIVED

• Alonso CD, Tillotson GS, Bidell MR, Guthmueller B, Hoeyer F, Fischer M, Dubberke ER. Safety and Efficacy of Fecal Microbiota, Live-jslm, in Preventing Recurrent Clostridioides difficile Infection in Participants Who Were Mildly to Moderately Immunocompromised in the Phase 3 PUNCH CD3-OLS Study. Open Forum Infect Dis. 2025 Mar 4;12(4):ofaf117. doi: 10.1093/ofid/ofaf117. eCollection 2025 Apr.

  PMID: 40177588 DERIVED

• Feuerstadt P, Chopra T, Knapple W, Van Hise NW, Dubberke ER, Baggott B, Guthmueller B, Bancke L, Gamborg M, Steiner TS, Van Handel D, Khanna S. PUNCH CD3-OLS: A Phase 3 Prospective Observational Cohort Study to Evaluate the Safety and Efficacy of Fecal Microbiota, Live-jslm (REBYOTA) in Adults With Recurrent Clostridioides difficile Infection. Clin Infect Dis. 2025 Feb 5;80(1):43-51. doi: 10.1093/cid/ciae437.

  PMID: 39180326 DERIVED

MeSH Terms

Conditions

Clostridium Infections; Infections; Communicable Diseases; Diarrhea; Enterocolitis, Pseudomembranous

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Clinical Development
• Organization: Clinical Development

US8-Studyinfo@ferring.com

651-705-8778

Study Officials

• Teena Chopra, M.D., M.P.H.

  Wayne State University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: April 30, 2019
• Study Start: July 30, 2019
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2023-04

Locations

US (46); CA (5)