About the Ri-CoDIFy Clinical Trial
Ri-CoDIFy 1 and Ri-CoDIFy 2 are global, Phase 3 clinical trials designed to test how well ridinilazole (trial medicine) works in treating CDI compared to vancomycin (standard of care medicine). A positive Phase 3 outcome may allow for the trial medicine (ridinilazole) to be approved by regulatory authorities and make it available as a potential option for the treatment of first episode of CDI or to reduce recurrence of CDI.
Both clinical trials are testing for Sustained Clinical Response (SCR) as the primary endpoint, or main measure of success. SCR means a patient is free from disease after ten days of treatment and remains free from CDI for 30 days after treatment ends.
The Phase 3 clinical trials will also measure the safety and tolerability of ridinilazole, as well as various health economics and outcomes research measures, including hospital readmission rates, lengths of hospital stays, and patient-reported outcomes.
What is involved?
If you join the Ri-CoDIFy Clinical trial, you will be in the trial for about 15 weeks.
We will ask you to take the trial medicine tablet (ridinilazole) or standard of care medicine capsule (vancomycin) four times a day for 10 days. Your part in the trial ends 13 weeks later with a safety follow-up visit.
You will remain in contact with the site through visits or calls through the fifteen weeks. Trial visits will include health checks, such as medical questionnaires, laboratory assessments, and physical examinations. You will receive care from a trial doctor with experience in treating patients with C. diff, and you will be checked regularly.
What medicine will be tested?
The trial drug is an investigational medicine because it has not yet been approved to treat people with CDI.
It will not be approved for use until clinical trials, such as the Ri-CoDIFy Clinical trial, show that it is safe (causes no harm) and effective (works).