CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
CRS3123 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04781387
NCT04781387Phase 2Completed
CompareCT.gov

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

Crestone, Inc·interventional·Posted Mar 4, 2021·Updated Mar 27, 2026

In Brief

A Phase 2 clinical trial evaluating CRS3123 and Active Comparator for Clostridioides Difficile Infection. Completed, enrolled 43 participants across 20 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridioides Difficile Infection
CountriesCanada, United States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 4, 2021
Enrollment StartJan 5, 2021
Primary CompletionApr 16, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.3 years ago

Interventions

CRS3123drug

Study drug dosed PO BID for a total of 10 days

Active Comparatordrug

Active comparator dosed PO QID for 10 days