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NCT05753215 · ClinicalTrials.gov registry record · Phase 2
Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection
A Phase 2 study of Joint Infection and Bone and Joint Infection, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT05753215 is a Phase 2 study of Joint Infection and Bone and Joint Infection that is active but no longer recruiting, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The registered enrollment target is 180 participants, below the 389-participant average among 6 other Joint Infection trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05753215, a Phase 2 study of Joint Infection and Bone and Joint Infection, is active but no longer recruiting, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study 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. At 12 weeks, if the treating physician wishes to extend therapy, participants receiving omadacycline will be transitioned to other SOC antibiotics. Once enrolled, participants will be followed via in-person clinic visits at the following intervals: weeks 0, 2, 4, 8, and 12. A final in-person visit will occur 2 weeks post-treatment completion. A phone survey will occur 3 months post-treatment completion. Participants in the SOC group will follow the same schedule. Oral once-daily dosing options for S. aureus and Coagulase negative Staphylococcus are essentially non-existent. Thus, omadacycline possesses a novel and advantageous option for BJI treatment. Its convenient dosing regimen will almost certainly be associated with improved adherence, and higher adherence may, in turn, improve clinical outcome. Investigators hypothesize that omadacycline will be a well-tolerated and efficacious oral antibiotic for BJIs and will be associated with improved adherence compared with standard of care oral antibiotics. Investigators believe omadacycline addresses the unmet need for an oral antibiotic that is well-tolerated and efficacious for use as a prolonged therapy for BJIs. To this aim, investigators will perform a randomized, open-label clinical trial of omadacycline to SOC antibiotics for BJIs.
Conditions Studied
Interventions
- DRUG Standard of Care
- DRUG Omadacycline Pill
Study Locations (1)
California
- The Lundquist Institute For Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2023-05-09 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05753215
The ClinicalTrials.gov registry entry for NCT05753215 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 389-participant average among 6 other Joint Infection trials with a reported enrollment target (54% lower). The listed sponsor is Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Joint Infection appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT05753215 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05753215 about?
NCT05753215 is a clinical study titled "Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection". 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 prosthet...
What is the current status of trial NCT05753215?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2023-05-09. Estimated completion is 2026-06.
What conditions does trial NCT05753215 study?
This clinical trial studies the following conditions: Joint Infection, Bone and Joint Infection, Bone Infection.
What interventions are being tested in trial NCT05753215?
The interventions under investigation include: Standard of Care (DRUG), Omadacycline Pill (DRUG).
Who is sponsoring clinical trial NCT05753215?
This trial is sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05753215 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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