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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03931941
Other study ID # 2019-01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 30, 2019
Est. completion date July 21, 2023

Study information

Verified date April 2023
Source Rebiotix Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 817
Est. completion date July 21, 2023
Est. primary completion date July 21, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. = 18 years old. 2. 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. 3. 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.] Exclusion Criteria: 1. Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI 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 or procedure. 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


Intervention

Drug:
RBX2660
RBX2660 is a microbiota suspension administered as an enema

Locations

Country Name City State
Canada Calgary Calgary Alberta
Canada Edmonton Edmonton Alberta
Canada Moncton Moncton New Brunswick
Canada Vancouver Vancouver British Columbia
Canada Victoria Victoria British Columbia
United States Annandale Annandale Virginia
United States Atlanta Atlanta Georgia
United States Aurora Aurora Colorado
United States Baltimore Baltimore Maryland
United States Burr Ridge Burr Ridge Illinois
United States Charleston Charleston South Carolina
United States Cleveland Cleveland Ohio
United States Dallas Dallas Texas
United States Decatur Decatur Georgia
United States Detroit Detroit Michigan
United States Durham Durham North Carolina
United States Fargo Fargo North Dakota
United States Fort Wayne Fort Wayne Indiana
United States Gainesville Gainesville Florida
United States Gurnee Gurnee Illinois
United States Hamden Hamden Connecticut
United States Hixon Hixon Tennessee
United States Houston Houston Texas
United States Idaho Falls Idaho Falls Idaho
United States Jacksonville Jacksonville Florida
United States Madison Madison Wisconsin
United States Marshfield Marshfield Wisconsin
United States Milwaukee Milwaukee Wisconsin
United States Naples Naples Florida
United States Nashville Nashville Tennessee
United States New Orleans New Orleans Louisiana
United States New York New York New York
United States North Little Rock North Little Rock Arkansas
United States Oklahoma City Oklahoma City Oklahoma
United States Orlando Orlando Florida
United States Oxnard Oxnard California
United States Philadelphia Philadelphia Pennsylvania
United States Phoenix Phoenix Arizona
United States Pittsburgh Pittsburgh Pennsylvania
United States Plymouth Plymouth Minnesota
United States Port Orange Port Orange Florida
United States Rochester Rochester Minnesota
United States Rochester Rochester New York
United States St. Louis Saint Louis Missouri
United States Seattle Seattle Washington
United States Shreveport Shreveport Louisiana
United States Spokane Spokane Washington
United States Springfield Springfield Virginia
United States West Jordan West Jordan Utah
United States Wichita Wichita Kansas
United States Wyomissing Wyomissing Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Rebiotix Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Efficacy of RBX2660 measured at 8 weeks after treatment. The absence of C. difficile diarrhea without the need for retreatment through 8 weeks after administration of the study treatment. 8 weeks after completing the study treatment
Secondary Sustained clinical response through 6 months after treatment. Treatment success of the presenting CDI recurrence and no new CDI episodes for greater than 8 weeks through 6 months after completing a study treatment assessed by subject phone interview up to 6 months after the last study treatment. 6 months after completing the study treatment
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