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

July 12, 2024 updated by: Rebiotix Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
793

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Calgary
      • Edmonton, Alberta, Canada, T6G 2X8
        • Edmonton
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver
      • Victoria, British Columbia, Canada, V8R 1J8
        • Victoria
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Moncton
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Phoenix
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • North Little Rock
    • California
      • Oxnard, California, United States, 93030
        • Oxnard
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Aurora
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Hamden
    • Florida
      • Gainesville, Florida, United States, 32610
        • Gainesville
      • Jacksonville, Florida, United States, 32224
        • Jacksonville
      • Naples, Florida, United States, 34102
        • Naples
      • Orlando, Florida, United States, 32806
        • Orlando
      • Port Orange, Florida, United States, 32127
        • Port Orange
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Atlanta
      • Decatur, Georgia, United States, 30033
        • Decatur
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Idaho Falls
    • Illinois
      • Burr Ridge, Illinois, United States, 60527
        • Burr Ridge
      • Gurnee, Illinois, United States, 60035
        • Gurnee
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Fort Wayne
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Wichita
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • New Orleans
      • Shreveport, Louisiana, United States, 71105
        • Shreveport
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Baltimore
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Detroit
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Plymouth
      • Rochester, Minnesota, United States, 55905
        • Rochester
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis
    • New York
      • New York, New York, United States, 10016
        • New York
      • Rochester, New York, United States, 14618
        • Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Durham
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Fargo
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Oklahoma City
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pittsburgh
      • Wyomissing, Pennsylvania, United States, 19610
        • Wyomissing
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Charleston
    • Tennessee
      • Hixon, Tennessee, United States, 37434
        • Hixon
      • Nashville, Tennessee, United States, 37212
        • Nashville
    • Texas
      • Dallas, Texas, United States, 75246
        • Dallas
      • Houston, Texas, United States, 77030
        • Houston
    • Utah
      • West Jordan, Utah, United States, 84088
        • West Jordan
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Annandale
      • Springfield, Virginia, United States, 22150
        • Springfield
    • Washington
      • Seattle, Washington, United States, 98104
        • Seattle
      • Spokane, Washington, United States, 99202
        • Spokane
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Madison
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield
      • Milwaukee, Wisconsin, United States, 53215
        • Milwaukee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active
RBX2660 is an enema of a microbiota suspension
Drug: RBX2660
RBX2660 is a microbiota suspension administered as an enema
Other Names:
  • Microbiota suspension

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI.
Time Frame: Up to 6 months after last study treatment.
Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).
Up to 6 months after last study treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy of RBX2660 Measured at 8 Weeks After Treatment.
Time Frame: 8 weeks after completing the study 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
Sustained Clinical Response Through 6 Months After Treatment.
Time Frame: 6 months after completing the study 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rebiotix Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Teena Chopra, M.D., M.P.H., Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-01 (Other Identifier: NANT)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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