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

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.

Timeline

Start

2021-01-05

Primary completion

2024-04-16

Completion

2024-04-16

Publications

• Louie T, Ribble W, Boccumini L, Johnson K, De Groote MA, Day J, Mason C, Sun X, Freeman J, Gu K, Tillotson G, Wilcox MH, Janjic N, Jarvis TC, Nayak SU, Ochsner UA, Bruss JB. Safety and efficacy of CRS3123 in adults with a primary episode or first recurrence of Clostridioides difficile infection: a phase 2, randomised, double-blind, multicentre, vancomycin-controlled study. Lancet Infect Dis. 2026 May;26(5):535-548. doi: 10.1016/S1473-3099(25)00721-2. Epub 2026 Jan 22.

Drugs

Indications