Treatment of bone and joint infections with omadacycline

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

This study is testing if a new antibiotic called omadacycline works better than standard antibiotics for treating bone and joint infections.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Academic / other)
• Locations: 1 site (Torrance, California)
• Trial ID: NCT05753215 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, open-label study comparing omadacycline to standard of care antibiotics for treating bone and joint infections (BJIs). Participants will be assigned to receive either omadacycline or the standard treatment chosen by their physician, with therapy lasting between 4 to 12 weeks. The study aims to evaluate the safety, tolerability, and effectiveness of omadacycline over a follow-up period of 16 to 24 weeks. Participants will be monitored through regular clinic visits to assess their progress and any necessary adjustments to their treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 diagnosed with a bone or joint infection that is expected to respond to omadacycline.

Not a fit: Patients requiring indefinite antibiotic treatment or those unable to take oral medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from bone and joint infections.

How similar studies have performed: While this approach is relatively novel, previous studies have shown promising results with omadacycline in treating other infections.

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

Where this trial is running

Torrance, California

• The Lundquist Institute For Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States (Recruiting)

Study contacts

• Principal investigator: Loren G. Miller, MD, MPH — The Lundquist Institute For Biomedical Innovation at Harbor-UCLA Medical Center
• Study coordinator: Donna Phan Tran, MPH

Conditions Bone Infection; Joint Infection; Bone and Joint Infection