Crestone, Inc
The purpose of this research is to evaluate the primary objectives of safety and efficacy (rate of clinical cure) of 2 dosages of CRS3123 (200 mg and 400 mg) administered orally (po) twice daily (bid) and vancomycin administered 125 mg PO 4 times daily (qid) in adults \> or equal to 18 years of age with a primary episode or first recurrence of CDI. The study will investigate the plasma concentrations and HRQoL outcomes of CRS3123 and additional efficacy endpoints as secondary objectives.
Clostridioides Difficile Infection
CRS3123
Active Comparator
PHASE2
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 108 participants |
Masking : | QUADRUPLE |
Primary Purpose : | TREATMENT |
Official Title : | A Phase 2, Randomized, Double-Blind, Comparator-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of CRS3123 Compared With Oral Vancomycin in Adults With Clostridioides Difficile Infection |
Actual Study Start Date : | 2021-01-05 |
Estimated Primary Completion Date : | 2024-02 |
Estimated Study Completion Date : | 2024-04 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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University of Calgary/Foothills Medical Center Alberta Health Services
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London Health Sciences Center and St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2