New daily pill could simplify tough bone infection treatment
NCT ID NCT05753215
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new antibiotic called omadacycline, taken once a day by mouth, against standard antibiotics for bone and joint infections. About 180 adults with these infections will be randomly assigned to receive either omadacycline or the usual care. The goal is to see if omadacycline works just as well and is easier for patients to stick with.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Lundquist Institute For Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
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Other studies related to the condition(s) this trial covers.
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