Treatment of Recurrent Clostridium Difficile Infection With RBX7455
Phase 1
Completed
- Conditions
- Clostridium Difficile Infection
- Interventions
- Biological: RBX7455
- Registration Number
- NCT02981316
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of RBX7455 for the treatment of recurrent CDI in subjects who have had at least one recurrence after a primary episode (i.e., at least two episodes) and have completed at least two rounds of standard-of-care oral antibiotic therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RBX7455 Group C RBX7455 2 days of 2 capsules twice daily RBX7455 for 10 subjects. RBX7455 Group B RBX7455 2 days of 4 capsules twice daily RBX7455 for 10 subjects. RBX7455 Group A RBX7455 4 days of 4 capsules twice daily RBX7455 for 10 subjects. RBX7455 Group D RBX7455 2 days of 1 capsule twice daily RBX7455 for 10 subjects.
- Primary Outcome Measures
Name Time Method Time to recurrence of Clostridium Difficile Infection (CDI) approximately 8 weeks Number of patients experiencing adverse events approximately 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States