NCT03595553

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

A Phase 3, Randomized, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Ridinilazole (200 mg, Bid) for 10 Days With Vancomycin (125 mg, Qid) for 10 Days in the Treatment of Clostridium Difficile Infection (CDI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 759 (actual)
• Sponsor: Summit Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects treated with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin. Ridinilazole plasma concentration will be assessed in a subset of patients.

Conditions

• Clostridioides Difficile Infection

Interventions

Type	Name	Description
DRUG	Ridinilazole	ridinilazole (200 mg bid)
DRUG	Vancomycin	vancomycin (125 mg qid)

Timeline

• Start date: 2019-01-28
• Primary completion: 2021-11-17
• Completion: 2021-11-17
• First posted: 2018-07-23
• Last updated: 2023-03-03
• Results posted: 2023-03-03

Locations

149 sites across 14 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Greece, Hungary, New Zealand, Poland, Romania, Russia, South Korea, Spain

Regulatory

• FDA-regulated drug study