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Ridinilazole · Ri-CoDIFy 1

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

Ensayo de Summit Therapeutics Inc. en Clostridioides Difficile Infection (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

759

previstos

Centros

149

Fin del objetivo primario

nov 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ene 2019.

Qué mide

Number of Participants With Sustained Clinical Response (SCR) Defined as Clinical Response and no Recurrence of CDI Through 30 Days Post End of Treatment (EOT). (del registro, en inglés) (dia 40)

Cómo lo describe el promotor

En el documentoEn inglés, del registroSummit 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.

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Ficha completa en ClinicalTrials.gov (NCT03595553), actualizada en mar 2023.