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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01925417
Recruitment Status : Completed
First Posted : August 19, 2013
Results First Posted : July 1, 2015
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.

Tracking Information
First Submitted Date  ICMJE August 15, 2013
First Posted Date  ICMJE August 19, 2013
Results First Submitted Date  ICMJE May 28, 2015
Results First Posted Date  ICMJE July 1, 2015
Last Update Posted Date November 13, 2019
Study Start Date  ICMJE August 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2013)
Safety [ Time Frame: 56 days ]
Safety will be assessed by evaluating the incidence, severity, and relatedness of serious adverse events through 56 days after the last treatment with RBX2660.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2013)
  • Long-term Safety [ Time Frame: 6 months ]
    Serious adverse events will be assessed through 6 months after the last treatment with RBX2660.
  • Efficacy [ Time Frame: 56 days ]
    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 ]
    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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Clostridium Difficile Infection
Intervention  ICMJE Biological: RBX2660 (microbiota suspension)
Study Arms  ICMJE Experimental: RBX2660 (microbiota suspension)
enema-based delivery of RBX2660
Intervention: Biological: RBX2660 (microbiota suspension)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2015)
34
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2013)
40
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01925417
Other Study ID Numbers  ICMJE 2013-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rebiotix Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rebiotix Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Dimitri Drekonja, MD Veteran Administration Medical Center
PRS Account Rebiotix Inc.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP