Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Alpesh Amin, MD

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

Locations

  • UCI Center for Clinical Research accepting new patients
    Orange California 92868 United States
  • Ascada Research accepting new patients
    Fullerton California 92835 United States

Lead Scientist at UC Irvine

  • Alpesh Amin, MD
    Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 237 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Crestone, Inc
ID
NCT04781387
Phase
Phase 2 C. Diff Research Study
Study Type
Interventional
Participants
Expecting 108 study participants
Last Updated