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Tetracycline Antibiotic
Omadacycline for Bone and Joint Infections (CORGI Trial)
Phase 2
Recruiting
Led By Amy Y. Kang, PharmD, BCIDP
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
CORGI Trial 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.Check my eligibility
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.See study design
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.
CORGI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post-therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Quantify the long term efficacy of omadacycline for BJIs, both non-hardware and hardware associated after therapy completion.
CORGI 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
Find a Location
Who is running the clinical trial?
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor
101 Previous Clinical Trials
46,121 Total Patients Enrolled
Paratek Pharmaceuticals IncIndustry Sponsor
16 Previous Clinical Trials
3,833 Total Patients Enrolled
Chapman UniversityOTHER
6 Previous Clinical Trials
1,201 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend all required follow-up visits at the research clinic.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.I am on a short-term antibiotics course, not for chronic use.My bone or joint infection is caused by fungi or mycobacteria.I have been diagnosed with a bone or joint infection.I plan to receive my cancer treatment as an outpatient.I have completed IV treatment for a blood infection and now need oral medication.I can take pills by mouth.I am between 18 and 85 years old.My treatment is scheduled to last between 4 to 12 weeks.My bone or joint infection is likely treatable with omadacycline.
Research Study Groups:
This trial has the following groups:- Group 1: standard of care antibiotic
- Group 2: omadacycline
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for me to participate in this research endeavor?
"The eligibility criteria for enrolment in this trial require that candidates have been diagnosed with osteomyelitis and are between 18-85 years old. This clinical study is planned to recruit a total of 180 participants."
Answered by AI
Is participation in this research initiative open to seniors aged 65 and older?
"This clinical trial can only accept applicants between 18 to 85 years old. There are an additional 196 trials for underage individuals and 601 trials available for senior citizens."
Answered by AI
Is this study actively seeking new volunteers?
"As indicated on clinicaltrials.gov, this research project is no longer recruiting patients; the trial was initially posted and last modified on March 1st of 2023. Despite not enrolling any further participants, 758 other trials are currently looking for volunteers to join them in their scientific endeavour."
Answered by AI
Has the Food and Drug Administration officially endorsed omadacycline for medical use?
"With safety data corroborating its use, omadacycline has been assigned a rating of 2. This reflects the fact that this is an experimental phase two trial and there have not yet been any studies to confirm its efficacy."
Answered by AI
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