NCT04781387

Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Crestone, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridioides Difficile Infection

Interventions

Type	Name	Description
DRUG	CRS3123	Study drug dosed PO BID for a total of 10 days
DRUG	Active Comparator	Active comparator dosed PO QID for 10 days

Timeline

• Start date: 2021-01-05
• Primary completion: 2024-04-16
• Completion: 2024-04-16
• First posted: 2021-03-04
• Last updated: 2026-03-27
• Results posted: 2025-05-25

Locations

20 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study