What is the purpose of the study?
The purpose of this research is to study new options for bone and joint infections. Bone and joint infections are common infections treated with oral (by mouth)and/or intravenous (through vein, also called "IV") antibiotics. However, because many germs causing these infections are resistant to our current antibiotics, we need to understand how newer antibiotics that treat many of these antibiotic-resistant germs work for bone infection.
Omadacycline is a Food and Drug Administration (FDA) approved newer type of antibiotic that is administered through IV or oral and used to treat community acquired bacterial pneumonia (called CABP) and acute bacterial skin and skin structure infections (called ABSSSI). It works by killing bacteria or preventing their growth. The FDA has not approved omadacycline for the treatment of bone and joint infections. This study is being done to see if omadacycline will be a safe, effective and tolerable (able to take without bad effects) treatment for bone and joint infections.
Who can participate in this study?
If you are between the age of 18-85 and have a current bone and/or joint infection that needs to be treated with antibiotic for at least 4 weeks you may be able to participate.
What will I need to do as a participant in this study?
If you take part in this study, you agree to:
Come to the study clinic between 3 and 5 visits depending on how long you take antibiotics for. These visits will be in addition to the follow-up appointments that your treating/primary physician will require of you as part of routine standard of care.
Take either the standard of care antibiotic(s) that is prescribed by your provider(s) or omadacycline with or without other antibiotic(s) between 4 and 12 weeks, as recommended by infectious disease specialists.
Provide blood samples (about 2 tablespoons each time) from your vein in your arm for laboratory tests.
Answer questions on your infection, any medications taken (including those you can buy over the counter), any information given to you by your primary/treating physician.
Maintain a medication diary.
Receive a call 3 months after your last dose of antibiotic to answer questions about your infection, any surgical procedures for your infection and if you been hospitalized since the last time, we saw you in person.
Will I be compensated for participating in this study?
There will be no cost or charges to you for taking part in this study.
The total amount you receive will depend on how long you take the antibiotic and the number of visits you make to the study site. You will receive at least a total of $230 for your participation. You will receive payment in the form of cash at each visit with the exception of the 3-month phone contact. We may mail you a check or you may return to the study site to receive the cash.
This study is registered on Clinicaltrials.gov under the identifier NCT05753215.
CORGI Research Team
© 2023 ID CORE at The Lundquist Institute For Biomedical Innovation at Harbor-UCLA Medical Center