At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 272 enrolled
Drug / intervention
RBX2660 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
In Brief
A Phase 2 clinical trial evaluating RBX2660 and Standard of Care Antibiotics for Clostridium Difficile Infection. Completed, enrolled 272 participants across 30 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile Infection
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartOct 2015
First PostedOct 2015
Primary CompletionJun 2017
Study CompletionMar 2019
TodayJul 2026
First PostedOct 28, 2015
Enrollment StartOct 1, 2015
Primary CompletionJun 1, 2017
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.7 years ago
Interventions
RBX2660biological
suspension of intestinal microbes
Standard of Care Antibioticsdrug
Standard of Care Antibiotics