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NCT02589847 · ClinicalTrials.gov registry record · Phase 2
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
A Phase 2 study of Clostridium Difficile Infection, sponsored by Rebiotix.
- Completed
- Registry status
- Phase 2
- Development phase
- 272
- Enrollment target
- 20
- Study locations
NCT02589847: Completed Phase 2 study of Clostridium Difficile Infection, sponsored by Rebiotix.
NCT02589847 is a Phase 2 study of Clostridium Difficile Infection that has completed, run by Rebiotix. The registered enrollment target is 272 participants, below the 12,045-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02589847, a Phase 2 study of Clostridium Difficile Infection, has completed, sponsored by Rebiotix.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 272 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will receive one treatment consisting of two doses of RBX2660 (microbiota suspension).
Primary Outcome
Participants were evaluated 8 weeks after study treatment to assess efficacy of RBX2660. Efficacy was assessed as the absence of CDI diarrhea without the need for retreatment with C. difficile anti-infective therapy or fecal transplant through 56 days after completion of study treatment.
Conditions Studied
Interventions
- BIOLOGICAL RBX2660
- DRUG Standard of Care Antibiotics
Study Locations (20)
Florida
- - Bay Pines
- - Coral Springs
- - Gainesville
- - Miami
Illinois
- - Chicago
- - Maywood
Indiana
- - Indianapolis
- - Lafayette
Minnesota
- - Rochester
- - Saint Paul
New York
- - Flushing
- - Rochester
Arizona
- - Phoenix
Arkansas
- - North Little Rock
California
- - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2015-10 |
| Est. Completion | 2019-03 |
| Phase | Phase 2 |
What the finished NCT02589847 record still lists
NCT02589847 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, below the 12,045-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Clostridium Difficile Infection appearing as the primary indexed condition, and to 2 interventions - of which RBX2660 is the first listed.
NCT02589847 names 20 study sites across 13 states, led by Florida, Illinois, Indiana.
Frequently Asked Questions
What is clinical trial NCT02589847 about?
NCT02589847 is a clinical study titled "Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection". This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will receive one treatment consist...
What is the current status of trial NCT02589847?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 272 participants. The study started on 2015-10. Estimated completion is 2019-03.
What conditions does trial NCT02589847 study?
This clinical trial studies the following conditions: Clostridium Difficile Infection.
What interventions are being tested in trial NCT02589847?
The interventions under investigation include: RBX2660 (BIOLOGICAL), Standard of Care Antibiotics (DRUG).
Who is sponsoring clinical trial NCT02589847?
This trial is sponsored by Rebiotix, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02589847 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02589847's enrollment target sits among peer trials
272 5th of 13 higher than 9 of 13 other Clostridium Difficile Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clostridium Difficile Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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