Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection

Launched by LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER · Mar 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new oral antibiotic called omadacycline to see how well it works for treating bone and joint infections, compared to standard antibiotics that are currently used. Bone and joint infections can be serious, and this study aims to find out if omadacycline is a good option for patients who need treatment for 4 to 12 weeks. Eligible participants must be between the ages of 18 and 85 and have a confirmed or likely bone or joint infection. They should also be able to take oral medications and attend follow-up visits at the clinic.

Participants in the trial will receive either omadacycline or the standard antibiotic treatment chosen by their doctor. They will have regular check-ins at the clinic over 12 weeks to monitor their progress, and there will be one final visit two weeks after treatment ends. This study is important because it aims to provide a more convenient oral option for patients, which could help them stick to their treatment better and improve their overall health outcomes.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Diagnosis of BJI or probable BJI as defined clinically using radiologic (e.g., MRI), surgical (e.g., intra-operative findings), and/or clinical (e.g., probe to bone) definitions
• • 2. BJI caused by or suspected to be caused by organisms that omadacycline is expected to be active against
• • 3. Planned treatment duration of 4-12 weeks
• • 4. Plans to continue or initiate treatment in outpatient setting
• • 5. Age 18-85
• • 6. Limited planned course of antibiotics (i.e., no indefinite treatment plans for chronic suppression)
• • 7. Able to take oral medications
• • 8. Able to come to the research clinic for study follow-up visits for the study period
• • 9. If a woman is of childbearing potential, she must consistently use two acceptable methods of contraception (IUD, injectable contraceptive, birth control patch, OCP, barrier method, abstinence) from baseline through the course of antibiotics (4-12 weeks). If a male patient's sexual partner is of childbearing potential, the male patient must acknowledge that they will consistently use an acceptable method of contraception as defined above from baseline through the course of antibiotics (4-12 weeks)
• Exclusion Criteria:
• • 1. Pregnancy or breast feeding. Women of childbearing potential must have a negative urine or serum pregnancy test result within 1 day prior to initiation of study drug
• • 2. Hypersensitivity to tetracycline-class antibiotics
• • 3. BJI caused by fungi or mycobacteria
• • 4. BJI complicated by endocarditis, central nervous system involvement such as subdural abscess, or any foci of metastatic infection, such as renal or splenic abscesses
• • 5. Prosthetic joint infections that have not undergone both stages of two stages of surgical treatments (i.e., subjects are only eligible after the 2nd stage surgery has been completed and typically 6 weeks of IV therapy has been completed)
• • 6. Hematogenous BJI prior to adequate treatment for bacteremia (i.e., subjects are only eligible after adequate IV course of bacteremia is completed and additional oral therapy is still required for infection "mop up")
• • 7. Any medical, psychological, or social condition that, in the opinion of the Investigator, would prevent the patient from fully participating in the study or would represent a concern for study compliance or constitute a safety concern to the patient