Comparing the effectiveness of an experimental drug with an FDA approved drug in the treatment of Clostridium difficile-associated diarrhea (CDAD)
Study Summary
The University of Chicago and Dr. Mullane are conducting a study to compare the effectiveness of an experimental drug with the standard FDA approved treatment for people diagnosed with Clostridium difficile-Associated Diarrhea (CDAD).
Clostridium difficile-associated diarrhea is a significant problem in hospitals, long term care facilities and in the community. Clostridium difficile (C. difficile) is a bacterium that causes infection of the colon (large bowel or intestines). C. difficile produces toxins (chemicals) that cause diarrhea, stomach pain, fever, vomiting and dehydration.
If you qualify to be in the study and still wish to participate, you will be randomly assigned to receive one of the two study drugs. Some research study subjects will receive the experimental drug and others will receive the drug that is known to work against CDAD. You will take one pill 4 times a day for 10 days. These pills are the study drug and placebo (inactive drug).
The duration of the study is approximately 6 weeks and will include 3 visits to the study site (doctor’s office) unless you are hospitalized.
Benefits
If the study drug is effective, you may benefit by having some relief of symptoms. If symptoms do not improve you will be transferred to a standard therapy for CDAD recommended by your doctor. It is possible, however, that no therapeutic or other direct health benefits may result during or following completion of this study. Information from this study may help researchers understand the diagnosis and treatment of this disease.
Participation Details
Initial selection criteria include:
- Must be at least 18 years of age
- Must not be pregnant or breast feeding during the study
- Must be available for clinic visits for the duration of the study
- Must meet study medical criteria as evaluated by Dr. Mullane
- Must have diarrhea: defined as a change in bowel habits, with >3 unformed bowel movements in the 24 hours prior to randomization
- Presence of either toxin A or B of C. difficile in the stool
Study Director: Dr. Kate Mullane
Department: Infectious Diseases
For more information contact:
Jennifer Theusch
jtheusch@medicine.bsd.uchicago.edu
(773) 702-1665
IRB: #14525A
