DJ19- Clostridium Difficile Vaccine - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an investigational vaccine prevents severe diarrhea caused by a germ called Clostridium difficile (C diff).
c. Diff vaccine for older adults
Who Can Participate in the Study?
Adults over 50 who have with an increased risk of future contact with healthcare systems, for example:
- Have received antibiotics in the past 12 weeks
- Have made at least 10 outpatient medical visits in the past year
- Have been hospitalized for at least 2 nights in the past year
- Live in a nursing facility
- Have had 2 emergency room visits in the past year
What is Involved?
If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to receive
-- 3 doses of an investigational vaccine for the germ Clostridium difficile or
-- 3 doses of a placebo (an inactive substance).
- Return for 5 outpatient visits to the Duke Early Phase Clinical Research Unit over the course of 7 months., with a follow-up period for up to 3.5 years.
Blood will be drawn 3 times over the 7 months.
Additional blood and stool samples may be necessary if you experience diarrhea.