Recurrent Clostridium Difficile Infection Clinical Trial
— PUNCH CDOfficial 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
NCT number | NCT01925417 |
Other study ID # | 2013-001 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | August 2013 |
Est. completion date | July 2014 |
Verified date | September 2018 |
Source | Rebiotix Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | July 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Chevy Chase Clinical Research | Chevy Chase | Maryland |
United States | Edward Hines Jr VA Hospital (veterans only) | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | Denver Health and University of Colorado | Denver | Colorado |
United States | Detroit Medical Center | Detroit | Michigan |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Sanford Research/USD | Fargo | North Dakota |
United States | Borland-Groover Clinic | Jacksonville | Florida |
United States | Ochsner Clinic | New Orleans | Louisiana |
United States | Mayo Clinic Arizona | Phoenix | Arizona |
United States | Mayo Clinic - Minnesota | Rochester | Minnesota |
United States | Washington University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Rebiotix Inc. |
United States,
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. Review. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 56 days | |
Secondary | Long-term Safety | The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660. | 6 months | |
Secondary | 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. | 56 days | |
Secondary | 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. |
60 days | |
Secondary | Post-treatment Hospitalization Data | number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment. | 6 months |
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