The Ri-CoDIFy 3 Study
What is the purpose of the the Ri-CoDIFy 3 study?
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.