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 take the study drug or the existing CDI drug 4 times each day for 10 days. You will visit the study clinic up to 3 times for tests
and procedures and be asked to provide stool and blood samples.
- You will receive daily phone calls from study staff starting at 2 days before through 2 days after your last dose.
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.
Note: Some study visits will need to be completed at the study clinic, but others may be completed by phone or as a home visit.