Enterocolitis Clostridium Difficile Recurrent Clinical Trial
— PUNCHCD2Official title:
A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
| NCT number | NCT02299570 |
| Other study ID # | 2014-01 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | December 2014 |
| Est. completion date | January 2018 |
| Verified date | December 2020 |
| Source | Rebiotix Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) 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 CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | January 2018 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - = 18 years - Medical record documentation of recurrent CDI either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization. - Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics. - A positive stool test for the presence of C. difficile within 60 days prior to enrollment. Exclusion Criteria: - A known history of continued C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment. - Requires antibiotic therapy for a condition other than recurrent CDI. - 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. - Colostomy. - Planned surgery requiring perioperative antibiotics within 6 months of study enrollment. - Life expectancy of < 12 months. - Compromised immune system. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | St. Joseph's Hospital | Hamilton | Ontario |
| Canada | University of British Columbia | Vancouver | British Columbia |
| United States | University of Colorado | Aurora | Colorado |
| United States | Chevy Chase Clinical Research | Chevy Chase | Maryland |
| United States | Loyola University Chicago | Chicago | Illinois |
| United States | University of Chicago | Chicago | Illinois |
| United States | Louis Stokes Cleveland VA Medical Center | Cleveland | Ohio |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Sanford Health | Fargo | North Dakota |
| United States | New York Hospital Queens | Flushing | New York |
| United States | Grand Teton Research Group | Idaho Falls | Idaho |
| United States | Infectious Diseases of Indiana | Indianapolis | Indiana |
| United States | Borland-Groover Clinic | Jacksonville | Florida |
| United States | Regional Infectious Diseases and Infusion Center | Lima | Ohio |
| United States | New York-Presbyterian Hospital/Weill Cornell Medical College | New York | New York |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Mayo Clinic Arizona | Phoenix | Arizona |
| United States | Gastroenterology Group of Rochester | Rochester | New York |
| United States | Mayo Clinic Minnesota | Rochester | Minnesota |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Regions Hospital | Saint Paul | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Rebiotix Inc. |
United States, Canada,
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
Moayyedi P, Marshall JK, Yuan Y, Hunt R. Canadian Association of Gastroenterology position statement: fecal microbiota transplant therapy. Can J Gastroenterol Hepatol. 2014 Feb;28(2):66-8. — 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 | Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) | The primary endpoint is to evaluate treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema, of Group A (two enemas of RBX2660) vs. Group B (two enemas of placebo). | 8 weeks after last assigned study treatment | |
| Secondary | Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT) | Treatment Success was defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema | 8-weeks | |
| Secondary | Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT) | Treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema. | 8-weeks | |
| Secondary | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | The validated SF-36 scale was used to identify changes to quality of life (QoL) following study treatment. Each component is analyzed on a norm-based scoring (0-100) with a higher score representing an improvement in QoL. | 8-week | |
| Secondary | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema. | 8-weeks | |
| Secondary | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema. | 8-weeks | |
| Secondary | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema. | 8-weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02254811 -
FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff
|
Phase 2/Phase 3 |