Clinical trial NCT03931941: Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Rebiotix Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-30
Enrollment: 793
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI.
timeFrame: Up to 6 months after last study treatment.
Secondary outcomes:
measure: Efficacy of RBX2660 Measured at 8 Weeks After Treatment.
timeFrame: 8 weeks after completing the study treatment
measure: Sustained Clinical Response Through 6 Months After Treatment.
timeFrame: 6 months after completing the study treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix
state: Arizona
city: North Little Rock
country: United States
facility: North Little Rock
state: Arkansas
city: Oxnard
country: United States
facility: Oxnard
state: California
city: Aurora
country: United States
facility: Aurora
state: Colorado
city: Hamden
country: United States
facility: Hamden
state: Connecticut
city: Gainesville
country: United States
facility: Gainesville
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville
state: Florida
city: Naples
country: United States
facility: Naples
state: Florida
city: Orlando
country: United States
facility: Orlando
state: Florida
city: Port Orange
country: United States
facility: Port Orange
state: Florida
city: Atlanta
country: United States
facility: Atlanta
state: Georgia
city: Decatur
country: United States
facility: Decatur
state: Georgia
city: Idaho Falls
country: United States
facility: Idaho Falls
state: Idaho
city: Burr Ridge
country: United States
facility: Burr Ridge
state: Illinois
city: Gurnee
country: United States
facility: Gurnee
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne
state: Indiana
city: Wichita
country: United States
facility: Wichita
state: Kansas
city: New Orleans
country: United States
facility: New Orleans
state: Louisiana
city: Shreveport
country: United States
facility: Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore
state: Maryland
city: Detroit
country: United States
facility: Detroit
state: Michigan
city: Plymouth
country: United States
facility: Plymouth
state: Minnesota
city: Rochester
country: United States
facility: Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis
state: Missouri
city: New York
country: United States
facility: New York
state: New York
city: Rochester
country: United States
facility: Rochester
state: New York
city: Durham
country: United States
facility: Durham
state: North Carolina
city: Fargo
country: United States
facility: Fargo
state: North Dakota
city: Cleveland
country: United States
facility: Cleveland
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City
state: Oklahoma
city: Philadelphia
country: United States
facility: Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pittsburgh
state: Pennsylvania
city: Wyomissing
country: United States
facility: Wyomissing
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston
state: South Carolina
city: Hixon
country: United States
facility: Hixon
state: Tennessee
city: Nashville
country: United States
facility: Nashville
state: Tennessee
city: Dallas
country: United States
facility: Dallas
state: Texas
city: Houston
country: United States
facility: Houston
state: Texas
city: West Jordan
country: United States
facility: West Jordan
state: Utah
city: Annandale
country: United States
facility: Annandale
state: Virginia
city: Springfield
country: United States
facility: Springfield
state: Virginia
city: Seattle
country: United States
facility: Seattle
state: Washington
city: Spokane
country: United States
facility: Spokane
state: Washington
city: Madison
country: United States
facility: Madison
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield
state: Wisconsin
city: Milwaukee
country: United States
facility: Milwaukee
state: Wisconsin
city: Calgary
country: Canada
facility: Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Edmonton
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver
state: British Columbia
city: Victoria
country: Canada
facility: Victoria
state: British Columbia
city: Moncton
country: Canada
facility: Moncton
state: New Brunswick
Study officials:
affiliation: Wayne State University
name: Teena Chopra, M.D., M.P.H.
role: STUDY_CHAIR
References: