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

Primary Purpose

Clostridium Difficile Infection, Infection, Communicable Diseases

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RBX2660
Sponsored by
Rebiotix Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix
  • North Little Rock
  • Oxnard
  • Aurora
  • Hamden
  • Gainesville
  • Jacksonville
  • Naples
  • Orlando
  • Port Orange
  • Atlanta
  • Decatur
  • Idaho Falls
  • Burr Ridge
  • Gurnee
  • Fort Wayne
  • Wichita
  • New Orleans
  • Shreveport
  • Baltimore
  • Detroit
  • Plymouth
  • Rochester
  • St. Louis
  • New York
  • Rochester
  • Durham
  • Fargo
  • Cleveland
  • Oklahoma City
  • Philadelphia
  • Pittsburgh
  • Wyomissing
  • Charleston
  • Hixon
  • Nashville
  • Dallas
  • Houston
  • West Jordan
  • Annandale
  • Springfield
  • Seattle
  • Spokane
  • Madison
  • Marshfield
  • Milwaukee
  • Calgary
  • Edmonton
  • Vancouver
  • Victoria
  • Moncton

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

RBX2660 is an enema of a microbiota suspension

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 26, 2019
Last Updated
April 7, 2023
Sponsor
Rebiotix Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03931941
Brief Title
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
Acronym
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rebiotix Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
817 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
RBX2660 is an enema of a microbiota suspension
Intervention Type
Drug
Intervention Name(s)
RBX2660
Other Intervention Name(s)
Microbiota suspension
Intervention Description
RBX2660 is a microbiota suspension administered as an enema
Primary Outcome Measure Information:
Title
Safety and tolerability of RBX2660 in subjects with recurrent CDI.
Description
Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).
Time Frame
Up to 6 months after last study treatment.
Secondary Outcome Measure Information:
Title
Efficacy of RBX2660 measured at 8 weeks after treatment.
Description
The absence of C. difficile diarrhea without the need for retreatment through 8 weeks after administration of the study treatment.
Time Frame
8 weeks after completing the study treatment
Title
Sustained clinical response through 6 months after treatment.
Description
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.
Time Frame
6 months after completing the study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 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.] Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teena Chopra, M.D., M.P.H.
Organizational Affiliation
Wayne State University
Official's Role
Study Chair
Facility Information:
Facility Name
Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
North Little Rock
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Oxnard
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Hamden
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Port Orange
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Idaho Falls
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Burr Ridge
City
Burr Ridge
State/Province
Illinois
ZIP/Postal Code
60527
Country
United States
Facility Name
Gurnee
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Facility Name
Fort Wayne
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Plymouth
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Wyomissing
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Hixon
City
Hixon
State/Province
Tennessee
ZIP/Postal Code
37434
Country
United States
Facility Name
Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
West Jordan
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Annandale
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Springfield
City
Springfield
State/Province
Virginia
ZIP/Postal Code
22150
Country
United States
Facility Name
Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
Facility Name
Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Edmonton
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Victoria
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Moncton
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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