Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
Status:
Active, not recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
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.