Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
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.
1. More than or equal to 3 diarrheal stools/day in 24 hours prior to randomization and in
 the judgment of the investigator that C difficile is the likely causative agent for
 the diarrhea.

 2. Stool positive for C. difficile GDH plus Toxin A and/or B

 3. Participants with a primary episode or first recurrence of CDI are eligible

 4. In the judgement of the investigator, the expectation that the participant will
 survive with effective antibiotic therapy and appropriate supportive care for the
 anticipated duration of the study

 5. Participants may be either inpatient or outpatient