Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Cedar Park, Texas
Dates
study started
estimated completion

Description

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.

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

Keywords

Clostridioides Difficile Infection CDI Cdiff Infection Clostridiodes difficile infection Cdiff Infections Communicable Diseases Clostridium Infections CRS3123 Active Comparator CRS3123 200 milligram CRS3123 400 milligram Vancomycin 125 milligram

Eligibility

For people ages 18 years and up

  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

Location

  • Advanced Clinical Research-Be Well accepting new patients
    Cedar Park Texas 78613 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Crestone, Inc
Links
Sign up for this study
ID
NCT04781387
Phase
Phase 2
Study Type
Interventional
Last Updated