Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea (PUNCH CD)

October 30, 2019 updated by: Rebiotix Inc.

A Phase 2 Open-label Clinical Trial Demonstrating the Safety of RBX2660 Microbiota Suspension for the Treatment of Recurrent Clostridium Difficile-associated Diarrhea (CDAD): the PUNCH CD Study

This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is the first study of a microbiota suspension derived from intestinal microbes. The primary assessments for this open label, multi-center study are (i) occurrence of product-related adverse events and (ii) resolution of CDAD at 56 days after administration of RBX2660. Subjects will also be assessed for time to CDAD recurrence, quality of life changes, and number of hospitalizations and length of stay for recurrent CDAD. Study visits will be at 7, 30, and 60 days after RBX2660 administration with additional follow-up at 3 and 6 months post treatment. Patients who have had at least two recurrences of CDAD after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDAD resulting in hospitalization may be eligible for the study.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health and University of Colorado
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Borland-Groover Clinic
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60141
        • Edward Hines Jr VA Hospital (veterans only)
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48201
        • Detroit Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Minnesota
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Research/USD

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 years
  • Medical record documentation of CDAD either: a) at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or b) have had at least two episodes of severe CDAD resulting in hospitalization.
  • Willing and able to have an enema(s).
  • Already taking or will start a course of oral antibiotics for CDAD symptoms for 10-14 days, including at least seven days of oral vancomycin.
  • Willing and able to complete the required subject diary.

Exclusion Criteria:

  • Continued (uncontrolled) CDAD after completing a 10-14 day course of oral antibiotics.
  • Requires antibiotic therapy for a condition other than CDAD.
  • Previous fecal transplant prior to study enrollment.
  • History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
  • History of irritable bowel syndrome (IBS).
  • History of chronic diarrhea.
  • History of celiac disease.
  • History of cirrhosis of the liver or ascites.
  • Disease symptoms caused by a confirmed intestinal pathogen other than Clostridium difficile.
  • Has a colostomy.
  • Intraabdominal surgery within the last 60 days.
  • Evidence of active, severe colitis.
  • History of short gut syndrome or motility disorders.
  • Requires the regular use of medications that affect bowel motility (e.g., metoclopramide, narcotics, loperamide).
  • Planned therapy in the next 3 months that may cause diarrhea (e.g., chemotherapy).
  • Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
  • Life expectancy of < 12 months.
  • Compromised immune system, e.g., HIV infection (any CD4 count); AIDS-defining diagnosis or CD4 <200/mm3; inherited/primary immune disorders; immunodeficient or immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy; or current or recent (< 90 days) treatment with immunosuppressant medications.
  • Taking steroids (≥ 20 mg a day) or is expected to be on steroids for more than 30 days after enrollment.
  • Neutropenia (white blood cell count <1000 cells/µL).

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
Intervention / Treatment
Experimental: RBX2660 (microbiota suspension)
enema-based delivery of RBX2660
Biological: RBX2660 (microbiota suspension)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660
Time Frame: 56 days
Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.
56 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term Safety
Time Frame: 6 months
The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.
6 months
Absence of CDAD at 56 Days
Time Frame: 56 days
Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.
56 days
Quality of Life (SF-36)
Time Frame: 60 days

Quality of Life (SF-36) will be assessed by comparing the subject's baseline quality of life score to his/her scores obtained at the 7-, 30- and 60-day follow-up visits.

The scale is from 0-100, with higher scores meaning better outcomes.
60 days
Post-treatment Hospitalization Data
Time Frame: 6 months
number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.
6 months

Collaborators and Investigators

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

Sponsor

Rebiotix Inc.

Investigators

  • Study Chair: Dimitri Drekonja, MD, Veteran Administration Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (Estimate)

August 19, 2013

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-001

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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