Omadacycline for Bone and Joint Infections (CORGI Trial)

Phase 2

Recruiting

Led By Loren G. Miller, MD, MPH

Research Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate a new antibiotic, omadacycline, for treating bone and joint infections, with the goal of improving adherence, safety and efficacy compared to existing antibiotics.

Who is the study for?

Adults aged 18-85 with bone and joint infections (BJI) suspected to be caused by gram-positive bacteria, needing 4-12 weeks of outpatient treatment. Participants must be able to take oral medication and attend clinic visits. Women of childbearing age must use two forms of contraception during the study.

What is being tested?

This trial is testing omadacycline pills against standard antibiotics for treating BJIs. Patients' treatments are chosen before they join, then randomly assigned to either the new pill or their pre-chosen standard care, followed up through clinic visits and phone surveys.

What are the potential side effects?

While specific side effects aren't listed here, as a tetracycline antibiotic, omadacycline may cause stomach upset, teeth discoloration in children, sun sensitivity, and rarely serious kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post-therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To compare the treatment success, as defined by lack of definite treatment failure, of omadacycline versus standard of care (SOC) antibiotics for bone and joint infections (BJIs) two weeks after therapy completion.

Secondary study objectives

Quantify the long term efficacy of omadacycline for BJIs, both non-hardware and hardware associated after therapy completion.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: standard of care antibioticExperimental Treatment1 Intervention

Standard of care as determined by primary care team

Group II: omadacyclineExperimental Treatment1 Intervention

Omadacycline will be administered 300 mg orally daily without the loading dose. We chose to omit the loading dose given that many of the enrolled subjects would have received an IV therapy prior to omadacycline initiation and notable gastrointestinal intolerabilities (nausea/vomiting) based on Phase-3 trial data. Subjects receiving omadacycline will be counseled on appropriate timing of administration (fast for 4 hours before dosing and no food for 2 hours after dosing) in light of the known food effects on drug absorption. They will be instructed to avoid use of products containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron containing preparations such as dairy, antacids, and multivitamins for 4 hours post-dosing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of Care

2017

Completed Phase 4

~4420

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