Back to resultsMicrobiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea (PUNCH CD)
Primary Purpose
Recurrent Clostridium Difficile Infection
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RBX2660 (microbiota suspension)
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Clostridium Difficile Infection focused on measuring Clostridium difficile, C diff, Microbiota Restoration Therapy, MRT, microbiota suspension, CDI, CDAD, Fecal transplant, Fecal Microbiota Transplant, FMT, Diarrhea, Fecal bacteriotherapy
Eligibility 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).
Sites / Locations
- Mayo Clinic Arizona
- Denver Health and University of Colorado
- Borland-Groover Clinic
- Edward Hines Jr VA Hospital (veterans only)
- University of Chicago
- Ochsner Clinic
- Chevy Chase Clinical Research
- Beth Israel Deaconess Medical Center
- Detroit Medical Center
- Henry Ford Health System
- Mayo Clinic - Minnesota
- Washington University
- Sanford Research/USD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RBX2660 (microbiota suspension)
Arm Description
enema-based delivery of RBX2660
Outcomes
Primary Outcome Measures
Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660
Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.
Secondary Outcome Measures
Long-term Safety
The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.
Absence of CDAD at 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)
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
number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01925417
Brief Title
Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
Acronym
PUNCH CD
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rebiotix Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Clostridium Difficile Infection
Keywords
Clostridium difficile, C diff, Microbiota Restoration Therapy, MRT, microbiota suspension, CDI, CDAD, Fecal transplant, Fecal Microbiota Transplant, FMT, Diarrhea, Fecal bacteriotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RBX2660 (microbiota suspension)
Arm Type
Experimental
Arm Description
enema-based delivery of RBX2660
Intervention Type
Biological
Intervention Name(s)
RBX2660 (microbiota suspension)
Primary Outcome Measure Information:
Title
Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660
Description
Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Long-term Safety
Description
The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.
Time Frame
6 months
Title
Absence of CDAD at 56 Days
Description
Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.
Time Frame
56 days
Title
Quality of Life (SF-36)
Description
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.
Time Frame
60 days
Title
Post-treatment Hospitalization Data
Description
number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Drekonja, MD
Organizational Affiliation
Veteran Administration Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Denver Health and University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Edward Hines Jr VA Hospital (veterans only)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Detroit Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic - Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Sanford Research/USD
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23323867
Citation
van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
Results Reference
background
PubMed Identifier
22002980
Citation
Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.
Results Reference
background
PubMed Identifier
23152734
Citation
Rohlke F, Stollman N. Fecal microbiota transplantation in relapsing Clostridium difficile infection. Therap Adv Gastroenterol. 2012 Nov;5(6):403-20. doi: 10.1177/1756283X12453637.
Results Reference
background
PubMed Identifier
33593430
Citation
Langdon A, Schwartz DJ, Bulow C, Sun X, Hink T, Reske KA, Jones C, Burnham CD, Dubberke ER, Dantas G; CDC Prevention Epicenter Program. Microbiota restoration reduces antibiotic-resistant bacteria gut colonization in patients with recurrent Clostridioides difficile infection from the open-label PUNCH CD study. Genome Med. 2021 Feb 16;13(1):28. doi: 10.1186/s13073-021-00843-9.
Results Reference
derived
PubMed Identifier
26565008
Citation
Orenstein R, Dubberke E, Hardi R, Ray A, Mullane K, Pardi DS, Ramesh MS; PUNCH CD Investigators. Safety and Durability of RBX2660 (Microbiota Suspension) for Recurrent Clostridium difficile Infection: Results of the PUNCH CD Study. Clin Infect Dis. 2016 Mar 1;62(5):596-602. doi: 10.1093/cid/civ938. Epub 2015 Nov 12.
Results Reference
derived
Learn more about this trial
Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
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