Trial record 1 of 1 for:
NCT03244644
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
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| ClinicalTrials.gov Identifier: NCT03244644 |
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Recruitment Status :
Active, not recruiting
First Posted : August 9, 2017
Last Update Posted : February 18, 2020
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Sponsor:
Rebiotix Inc.
Information provided by (Responsible Party):
Rebiotix Inc.
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Brief Summary:
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Clostridium Difficile Infection | Drug: RBX2660 Drug: Placebo | Phase 3 |
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI and (ii) safety via assessment of adverse events. Follow-up office visits occur at weeks 1-, 4- and 8 after completing the blinded study treatment. Telephone assessments for adverse events occur during weeks 2, 3 and 6 after the study enema and at months 3 and 6. Patients who have had at least one recurrence after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization within the last year may be eligible for the study. Study Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 267 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection |
| Actual Study Start Date : | July 31, 2017 |
| Estimated Primary Completion Date : | June 2020 |
| Estimated Study Completion Date : | October 2020 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Group A
Placebo is an enema of normal saline. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding
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Drug: Placebo
Placebo is normal saline solution administered as an enema
Other Name: saline solution |
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Experimental: Group B
RBX2660 is an enema of a microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
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Drug: RBX2660
RBX2660 is a microbiota suspension administered as an enema
Other Name: microbiota suspension |
Primary Outcome Measures :
- Efficacy of RBX2660 compared to Placebo measured at 8 weeks [ Time Frame: 1, 4, and 8 weeks after completing the study treatment ]The absence of C. difficile diarrhea without the need for retreatment as assessed by subject interview and physical exam 1, 4, and 8 weeks after administration of the study treatment.
Secondary Outcome Measures :
- Number of subjects with adverse events through 6 months [ Time Frame: Up to 6 months after completing the study treatment ]Documented adverse events will be categorized by frequency, severity, seriousness, and causality as assessed by subject interview and physical exam at 1-week, 4-week, and 8-week visits, and by subject phone interviews at 3 and 6 months from the last study treatment received.
- Health Related Quality of Life (HRQOL) Assessment [ Time Frame: Up to 6 months after completing the study treatment ]Screening HRQOL scores will be compared to scores obtained at the 1-Week, 4-week, and 8-week assessment visits, and 3 and 6 month phone assessments
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ≥ 18 years old.
- Medical record documentation of recurrent CDI per the study definition, that includes either: a) at least one recurrence after a primary episode and has completed at least one round of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization within the last year.
- A positive stool test for the presence of toxigenic C. difficile within 30 days prior to or on the date of enrollment.
- Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment.
[Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking this course of antibiotics]
Exclusion Criteria:
- Currently has continued CDI diarrhea despite being on antibiotics prescribed for CDI treatment.
- Previous fecal transplant
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
- Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
- Compromised immune system (e.g. immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy)
- An absolute neutrophil count of <1000 cells/µL during screening.
- Pregnant, breastfeeding, or intends to become pregnant during study participation.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244644
Locations
Show 66 study locations
Sponsors and Collaborators
Rebiotix Inc.
Additional Information:
Publications:
Publications:
| Responsible Party: | Rebiotix Inc. |
| ClinicalTrials.gov Identifier: | NCT03244644 |
| Other Study ID Numbers: |
2017-01 |
| First Posted: | August 9, 2017 Key Record Dates |
| Last Update Posted: | February 18, 2020 |
| Last Verified: | February 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Rebiotix Inc.:
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C Difficile Colitis Clostridium Difficile CDI C.Difficile Diarrhea Fecal Transplant |
Fecal Microbiota Transplant Microbiota Restoration Therapy Diarrhea FMT Microbial Suspension |
Additional relevant MeSH terms:
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Infection Communicable Diseases Clostridium Infections Enterocolitis, Pseudomembranous Gram-Positive Bacterial Infections Bacterial Infections |
Enterocolitis Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |