ClinicalTrials.gov ID: NCT05753215

Official Title
Omadacycline Versus Standard-of-Care Oral Antibiotic Treatment for Bone and Joint Infections: an Open-Label, Non- Inferiority, Randomized, Controlled Trial

Brief Summary
The study design is a randomized, open-label, clinical trial of omadacycline vs Standard of Care (SOC) antibiotics for bone and join infection (BJI) treatment. Study participants will have their BJI regimen chosen by their treating physicians, (typically Infectious Diseases for hardware and prosthetic joint infections, or multidisciplinary Limb Salvage team for diabetic foot infections) prior to enrollment. Then participants will be randomized to an omadacycline-containing regimen versus the a priori chosen SOC regimen. Participants must require between 4 and 12 weeks of therapy for their BJI. The exact duration of therapy will be decided by the participants’ treating physician.

Detailed Description
The design of this study is a prospective, open-label, randomized clinical trial of omadacycline vs SOC antibiotics for the treatment of BJIs. We will follow subjects for between 16 and 24 weeks, depending on the length of their antibiotic treatment, for the purpose of determining tolerability, safety, and treatment success of prolonged use (> 4 weeks) of omadacycline in the treatment of BJIs. Subjects will be enrolled regardless of race, ethnicity, or gender (as long as they are within 18 – 85 years of age).
Subjects will be given omadacycline-containing regimen versus SOC. Omadacycline will be administered 300 mg orally daily without loading dose duration of therapy of between 4 and 12 weeks. The exact duration of therapy will be decided by the subject’s treating physician. In other words, the primary/consulting physician who is managing the treatment of the subject’s bone and joint infection will be the one who decides the length of the antibiotic treatment.
Safety and tolerability of omadacycline through this study will be guaranteed for 12 weeks. At 12 weeks, if the treating physician wishes to extend therapy, subjects receiving omadacycline will be transitioned to other SOC antibiotics. Medications will be provided by the Investigational Drug Service (IDS) on The Lundquist Institute/Harbor-UCLA campus, which supplies all research related medications to study subjects at our center.