The Ri-CoDIFy 3 Study

What is the purpose of the the Ri-CoDIFy 3 study?

The purpose of the Ri-CoDIFy 3 study is to find out if a new study drug is safe and works better than an existing drug for CDI (or C. diff.).

Who can join the Ri-CoDIFy 3 study?

Teenagers who meet the following study requirements* may be able to join the Ri-CoDIFy 3 study:

  • 12 to 17 years of age
  • Currently experiencing frequent diarrhea (3 or more episodes within 24 hours)
  • Have not taken antibiotics for more than 24 hours for the current case of CDI/diarrhea

*Other study requirements will apply.

What will happen during the study?

If you qualify and decide to join the Ri-CoDIFy 3 study, your participation will last about 3 months and will include the following periods:

Screening period (1 visit)

  • You will visit the study clinic for tests and procedures to find out if you can join the study.

Therapy period (10 days)

  • You will be assigned at random (like a coin flip) to receive either the study drug (ridinilazole) or an existing CDI drug (vancomycin). For every 4 participants in the study, 3 will receive ridinilazole, and 1 will receive vancomycin. Neither you nor the study staff will know which drug you receive.
  • You will take ridinilazole or vancomycin (whichever you are assigned) 4 times each day for 10 days.
  • You will visit the study clinic up to 3 times for tests and procedures, and you will likely be asked to provide stool samples.

Follow-up period (up to 90 days)

  • You will have up to 4 more visits at the study clinic, and you will receive a weekly phone call from study staff for a little over a month.
  • If the CDI is not better by Day 12, or if it gets better but comes back before Day 40, the study doctor will provide standard care for the infection.

For more information on the study, you can also reach out to medicalinformation@summitplc.com or +1 833 256 0522