Drug Study for the Treatment of Foot Infections (With or Without an Infection to the Bone) in Subjects with Diabetes

Study Summary

The University of Chicago and Dr. Mullane are conducting a study to test the effectiveness and safety of a once daily dose of an FDA-approved antibiotic drug used to treat certain types of infections in comparison to an FDA-approved drug used for the treatment of foot infections in subjects with diabetes. The drug being tested is considered "experimental" because it has not been approved by the FDA to treat diabetic foot infections. The antibiotics used in the study are not approved for the treatment of osteomyelitis (bone infection)

To qualify to participate in this study, you will undergo some tests and procedures such as a review of your medical history, a physical examination, an examination of your foot infection, an electrocardiogram (ECG), blood draws, x-rays of your infected foot, a sample will be taken from your foot infection, a urine sample will be collected for routine testing, and a possible magnetic resonance imaging (MRI) scan. If you qualify to be in the study and wish to participate, you will be randomly assigned to receive one of the two drugs involved in the study.

Your participation in this study can last approximately two months, which can include up to 42 days of study drug administration, one follow up visit and a final visit. You must stay in the hospital during the first four days of drug administration so that you can receive the study drug and your health can be monitored. After these initial days, you may be discharged from the hospital to receive the study drug outside of the hospital, if your study doctor feels that it is appropriate. A nurse will visit your home daily to administer your study drug and measure of your heart rate, respiratory rate, temperature, and blood pressure as well as draw blood samples for routine tests (done weekly).

You may not benefit directly from being in this research study. However, the information learned about this study drug and how it works may helpful to subjects with diabetic foot infections in the future.

Participation Details

• Must be at least 18 years of age
• Must not be pregnant or breastfeeding during the study
• Must be available for clinic visits during duration of study
• Must be hospitalized at time of enrollment
• Must have diabetes mellitus with a foot infection that does not extend above the knee
• Must meet study medical criteria as evaluated by Dr. Mullane
• Participation in this study is voluntary

Study Director: Dr. Kathleen Mullane
Department: Infectious Diseases

For more information contact:
Jennifer Theusch
jtheusch@medicine.bsd.uchicago.edu
(773) 702-1665

IRB: #15447B