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

Infection Clinical Trial

— CD3-OLS  

Official title:

A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (Microbiota Suspension) in Subjects With Recurrent Clostridium Difficile Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931941
• Other study ID #: 2019-01
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infection
• Infections

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