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

Completed · Phase 3

Conditions studied: Clostridium Difficile Infection, Infection, Communicable Diseases

In brief

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.

Key facts

Study ID

NCT03931941

Run by

Rebiotix Inc.

People needed

793

Starts

2019-07-30

Expected to finish

2023-07-21

Last updated by the study team

2024-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• North Little Rock — North Little Rock, Arkansas, United States
• Oxnard — Oxnard, California, United States
• Aurora — Aurora, Colorado, United States
• Hamden — Hamden, Connecticut, United States
• Gainesville — Gainesville, Florida, United States
• Jacksonville — Jacksonville, Florida, United States
• Naples — Naples, Florida, United States
• Orlando — Orlando, Florida, United States
• Port Orange — Port Orange, Florida, United States
• Atlanta — Atlanta, Georgia, United States
• Decatur — Decatur, Georgia, United States
• Idaho Falls — Idaho Falls, Idaho, United States
• Burr Ridge — Burr Ridge, Illinois, United States
• Gurnee — Gurnee, Illinois, United States
• Fort Wayne — Fort Wayne, Indiana, United States
• Wichita — Wichita, Kansas, United States
• New Orleans — New Orleans, Louisiana, United States
• Shreveport — Shreveport, Louisiana, United States
• Baltimore — Baltimore, Maryland, United States
• Detroit — Detroit, Michigan, United States
• Plymouth — Plymouth, Minnesota, United States
• Rochester — Rochester, Minnesota, United States
• St. Louis — St Louis, Missouri, United States
• New York — New York, New York, United States
• Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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