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DJ19- Clostridium Difficile Vaccine for Older Adults - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if a study vaccine prevents severe diarrhea caused by a germ called Clostridium Difficile (C Diff).

What is the Condition Being Studied?

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 gotten 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

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to get:
-- 3 doses of a study 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 month with a follow-up period for up to 3.5 years
- Have your blood drawn 3 times over 7 months

Study Details

Full Title
A Phase 3, Placebo-Controlled, Randomized, Observer-Blinded Study to Evaluate the Efficacy, Safety, and Tolerability of a Clostridium Difficile Vaccine in Adults 50 Years of Age and Older
Principal Investigator
Protocol Number
IRB:PRO00082496
NCT:NCT03090191
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698