Apply to Trial

Compensation: Varies

Number of Visits: 1

Duration: 4-12 weeks

180 Participants Needed

Omadacycline for Bone and Joint Infections
(CORGI Trial)

Recruiting at 1 trial location

Overseen ByDonna Phan Tran, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Must not be taking: Tetracyclines

Disqualifiers: Pregnancy, Fungi, Mycobacteria, Endocarditis, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new antibiotic, omadacycline, for treating bone and joint infections. The goal is to determine if omadacycline is as effective and easier to take than standard antibiotics, particularly because it can be taken orally once daily. Individuals with a bone or joint infection requiring 4 to 12 weeks of treatment and without a long-term antibiotic plan might be suitable candidates. Participants will be randomly assigned to either take omadacycline or follow their usual antibiotic treatment. The trial aims to assess whether omadacycline can improve treatment adherence and outcomes. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor to understand how your current medications might interact with the trial treatment.

Is there any evidence suggesting that omadacycline is likely to be safe for humans?

Research shows that patients usually tolerate omadacycline well. In a study of individuals with community-acquired bacterial pneumonia, only 1% of those taking omadacycline experienced diarrhea, compared to 8% of those on another antibiotic. This suggests omadacycline might cause fewer stomach issues.

However, some individuals may still experience nausea or vomiting. Doctors recommend taking it on an empty stomach for this reason. Omadacycline is approved for treating other infections, which supports its safety profile. As a pill, it is easier to use for bone and joint infections since it does not require injection.

Overall, while research indicates that omadacycline is safe, individual reactions to medications can vary. Consulting a healthcare provider is always advisable if there are any concerns.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising for bone and joint infections?

Omadacycline is unique because it offers a new approach to treating bone and joint infections by using a tetracycline-class antibiotic that can be taken orally. Unlike standard treatments, which often involve intravenous antibiotics like vancomycin or ceftriaxone, omadacycline can be administered without a loading dose and has specific guidelines to avoid food interactions, enhancing its practicality and ease of use. Researchers are excited because omadacycline's oral administration could simplify treatment regimens and improve patient compliance, potentially leading to better outcomes in managing these challenging infections.

What evidence suggests that omadacycline might be an effective treatment for bone and joint infections?

Research has shown that omadacycline, a treatment under study in this trial, may effectively treat bone and joint infections (BJIs). Participants may receive omadacycline, an oral antibiotic that is easy to take and may help people adhere to their treatment plan for better results. It is already approved for treating other infections, such as community-acquired bacterial pneumonia, supporting its safety and effectiveness. Overall, early evidence suggests that omadacycline could be a reliable choice for treating BJIs, offering a simpler and effective treatment option.¹ ³ ⁶ ⁷ ⁸

Who Is on the Research Team?

Amy Y. Kang, PharmD, BCIDP

Principal Investigator

Chapman Univeristy

Loren G Miller

Principal Investigator

The Lundquist Institute For Biomedical Innovation at Harbor-UCLA Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can attend all required follow-up visits at the research clinic.

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)

I am on a short-term antibiotics course, not for chronic use.

See 5 more

Exclusion Criteria

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

I have completed both surgeries and 6 weeks of IV therapy for my prosthetic joint infection.

My bone and joint infection is complicated by heart infection or brain abscesses.

See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either omadacycline or standard of care antibiotics for bone and joint infections, with therapy lasting between 4 and 12 weeks as decided by the treating physician.

4-12 weeks

In-person visits at weeks 0, 2, 4, 8, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a final in-person visit 2 weeks post-treatment and a phone survey 3 months post-treatment.

16-24 weeks

1 in-person visit, 1 phone survey

Extension

If necessary, participants may transition to other standard of care antibiotics after 12 weeks of omadacycline treatment.

What Are the Treatments Tested in This Trial?

Interventions

Omadacycline
Standard of Care

Trial Overview 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.

How Is the Trial Designed?

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.

Omadacycline is already approved in United States for the following indications:

Approved in United States as Nuzyra for:

Community-acquired bacterial pneumonia
Acute bacterial skin and skin structure infections

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Lead Sponsor

Trials

105

Recruited

46,600+

Paratek Pharmaceuticals Inc

Industry Sponsor

Trials

Recruited

4,000+

Chapman University

Collaborator

Trials

Recruited

920+

Published Research Related to This Trial

A review of over 30 antibiotics showed that most, including amoxicillin, vancomycin, and fluoroquinolones, effectively penetrate bone and joint tissues, reaching concentrations that exceed the minimum inhibitory concentrations (MIC) for common pathogens associated with infections.

However, some antibiotics like penicillin and metronidazole demonstrated poor penetration into bone and joint spaces, suggesting they may be less effective for treating these types of infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic penetration into bone and joints: An updated review.Thabit, AK., Fatani, DF., Bamakhrama, MS., et al.[2019]

Omadacycline, approved by the FDA in 2018, is an effective new antibiotic for treating community-acquired pneumonia and acute bacterial skin infections, showing promise against a wide range of bacteria.

This drug is a semisynthetic derivative of minocycline that can overcome common bacterial resistance mechanisms, making it a valuable option in the fight against resistant infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omadacycline: A Newly Approved Antibacterial from the Class of Tetracyclines.Durães, F., Sousa, E.[2020]

Linezolid, daptomycin, and telavancin show potential as treatment options for osteomyelitis caused by resistant gram-positive bacteria, with linezolid demonstrating significant bone penetration in human studies, but its use may be limited by side effects.

Daptomycin and telavancin may serve as alternatives to vancomycin for treating osteomyelitis, while tigecycline and ceftaroline lack sufficient clinical data and show poor bone penetration, limiting their effectiveness in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential role of newer gram-positive antibiotics in the setting of osteomyelitis of adults.Moenster, RP., Linneman, TW., Call, WB., et al.[2013]

Citations

1.sciencedirect.comsciencedirect.com/science/article/pii/S2213716525001031

In vitro activity of omadacycline against bacterial isolates ...Additionally, real world data has shown successful treatment with omadacycline as a single agent therapy with bone and joint infections, including mixed ...

2.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC10398854/

Real-world effectiveness of omadacycline and impact ...Patients with unfilled omadacycline prescriptions were more likely to have 30-day ED/hospital visits relative to patients with filled prescriptions.

3.clinicaltrials.govclinicaltrials.gov/study/NCT05753215

Controlled Trial of Omadacycline Randomized Treatment ...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 ...

4.firstwordpharma.comfirstwordpharma.com/story/6323887

Paratek Pharmaceuticals to Present New Data on NUZYRA ...NUZYRA (omadacycline) is a once-daily oral and intravenous antibiotic indicated for adults with community-acquired bacterial pneumonia (CABP) ...

5.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC11778859/

P-67. Safety of Omadacycline Versus ...Background. The incidence of bone and joint infections (BJIs) continues to increase, and existing oral BJI antibiotics have limitations.

6.nuzyra.comnuzyra.com/hcp/safety/cabp/

NUZYRA® (omadacycline) Safety in CABP PatientsIn OPTIC, 4 (1%) patients experienced diarrhea in the NUZYRA treatment group as compared to 31 (8%) patients in the moxifloxacin group.

7.digitalcommons.chapman.edudigitalcommons.chapman.edu/cgi/viewcontent.cgi?article=2110&context=pharmacy_articles

Safety of Omadacycline Versus Standard-of-Care Oral ...The incidence of bone and joint infections (BJIs) continues to in- crease, and existing oral BJI antibiotics have limitations. Omadacycline may ...

8.accessdata.fda.govaccessdata.fda.gov/drugsatfda_docs/label/2018/209816_209817lbl.pdf

NUZYRA (omadacycline) - accessdata.fda.govsafety and effectiveness of NUZYRA in treating clinical infections due to these microorganisms have not been established in adequate and well controlled ...

Other People Viewed

By Subject

By Trial

Omadacycline for Bone and Joint Infections
(CORGI Trial)

What You Need to Know Before You Apply

Who Is on the Research Team?

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Published Research Related to This Trial

Citations

Other People Viewed

Related Searches

Personalize Your Experience

Save Your Preferences

Understand How the Site Is Used

Omadacycline for Bone and Joint Infections (CORGI Trial)

What You Need to Know Before You Apply

Who Is on the Research Team?

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Published Research Related to This Trial

Citations

Other People Viewed

Related Searches

Omadacycline for Bone and Joint Infections
(CORGI Trial)