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Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

NCT03595553 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 759

Last updated 2023-03-03

Study results available
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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

DRUG

Ridinilazole

ridinilazole (200 mg bid)

DRUG

Vancomycin

vancomycin (125 mg qid)

Sponsors & Collaborators

  • Summit Therapeutics

    lead INDUSTRY

Principal Investigators

  • Lori Styles, MD · Summit Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2021-11-17
Completion
2021-11-17
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Greece
  • Hungary
  • New Zealand
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595553 on ClinicalTrials.gov