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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.
ClinicalTrials.gov Identifier:
NCT01925417
First received: August 15, 2013
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Recurrent Clostridium Difficile Infection
Biological: RBX2660 (microbiota suspension)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Rebiotix Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
    Safety will be assessed by evaluating the incidence, severity, and relatedness of serious adverse events through 56 days after the last treatment with RBX2660.


Secondary Outcome Measures:
  • Long-term Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Serious adverse events will be assessed through 6 months after the last treatment with RBX2660.

  • Efficacy [ Time Frame: 56 days ] [ Designated as safety issue: No ]
    Absence or presence of CDAD at Day 56 after receiving RBX2660. Subjects who reoccur before Day 56 may receive a second treatment with RBX2660 within 10 days of recurrence.

  • Quality of Life [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Quality of life 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.

  • Post-treatment Hospitalization Data [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Hospitalization cost, number of ICU days, and length of stay data will be collected for subjects who receive RBX2660 and who are subsequently hospitalized for recurrent CDAD treatment.


Estimated Enrollment: 40
Study Start Date: August 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RBX2660 (microbiota suspension) Biological: RBX2660 (microbiota suspension)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01925417

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

Publications:
Responsible Party: Rebiotix Inc.
ClinicalTrials.gov Identifier: NCT01925417     History of Changes
Other Study ID Numbers: 2013-001
Study First Received: August 15, 2013
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rebiotix Inc.:
Clostridium difficile
C diff
Microbiota Restoration Therapy
MRT
microbiota suspension
CDI
CDAD
Fecal transplant
Fecal Microbiota Transplant
FMT
Diarrhea
Fecal bacteriotherapy

Additional relevant MeSH terms:
Diarrhea
Clostridium Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 23, 2014