Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
Status:
Recruiting
Trial end date:
2022-02-21
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Crestone, Inc
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)