Home Welcome to the Infectious Diseases Clinical Outcomes Research Evaluation (ID-CORE) Unit

Welcome to the Infectious Diseases Clinical Outcomes Research Evaluation (ID-CORE) Unit

The ID-CORE team at The Lundquist Institute, based on the Harbor-UCLA Medical Center campus, provides high quality clinical research services, focusing on a variety of infectious diseases, both acute and chronic.

The team includes physicians, pharmacists, basic investigators, clinical research staff, phlebotomists, regulatory specialists, laboratory staff, and other staff focused on clinical trials. We have ample experience in innovative basic and applied research, clinical trials, epidemiology, and health services research and have led or participated in key breakthrough studies that address emerging challenges in infectious diseases.

Current Studies

CORGI
Join a trial that aims to find new treatment options for bone and joint infections, particularly focusing on omadacycline to assess its safety, effectiveness, and tolerability in treating antibiotic-resistant germs causing these infections. This study is enrolling adults with current bone and joint infection. 
What is the purpose of the study?

The purpose of this research is to study new options for bone and joint infections. Bone and joint infections are common infections treated with oral (by mouth)and/or intravenous (through vein, also called “IV”) antibiotics. However, because many germs causing these infections are resistant to our current antibiotics, we need to understand how newer antibiotics that treat many of these antibiotic-resistant germs work for bone infection.

Omadacycline is a Food and Drug Administration (FDA) approved newer type of antibiotic that is administered through IV or oral and used to treat community acquired bacterial pneumonia (called CABP) and acute bacterial skin and skin structure infections (called ABSSSI). It works by killing bacteria or preventing their growth. The FDA has not approved omadacycline for the treatment of bone and joint infections. This study is being done to see if omadacycline will be a safe, effective and tolerable (able to take without bad effects) treatment for bone and joint infections.

Who can participate in this study?

If you are between the age of 18-85 and have a current bone and/or joint infection that needs to be treated with antibiotic for at least 4 weeks you may be able to participate.

What will I need to do as a participant in this study?

If you take part in this study, you agree to:

  • Come to the study clinic between 3 and 5 visits depending on how long you take antibiotics for. These visits will be in addition to the follow-up appointments that your treating/primary physician will require of you as part of routine standard of care.
  • Take either the standard of care antibiotic(s) that is prescribed by your provider(s) or omadacycline with or without other antibiotic(s) between 4 and 12 weeks, as recommended by infectious disease specialists.
  • Provide blood samples (about 2 tablespoons each time) from your vein in your arm for laboratory tests.
  • Answer questions on your infection, any medications taken (including those you can buy over the counter), any information given to you by your primary/treating physician.
  • Maintain a medication diary.
  • Receive a call 3 months after your last dose of antibiotic to answer questions about your infection, any surgical procedures for your infection and if you been hospitalized since the last time, we saw you in person.
Will I be compensated for participating in this study?

There will be no cost or charges to you for taking part in this study.

The total amount you receive will depend on how long you take the antibiotic and the number of visits you make to the study site. You will receive at least a total of $230 for your participation. You will receive payment in the form of cash at each visit with the exception of the 3-month phone contact. We may mail you a check or you may return to the study site to receive the cash.

This study is registered on ClinicalTrials.gov under the identifier NCT05753215.

OPTIMIZE GNI
Join a trial that is testing better ways to measure kidney function in critically ill adults so doctors can safely and more accurately dose powerful antibiotics like meropenem and cefepime for serious infections.
What is the purpose of the study?

The purpose of this study is to gather data about how your body reacts, processes, and eliminates the antibiotic (meropenem or cefepime) that you are being given by your care team. The study of how your body interacts with and processes the medications you take is called pharmacokinetic/pharmacodynamic (PK/PD). This study will provide specific information about how varying levels of kidney function impacts the dosing of these antibiotics in adult patients who are in the intensive care unit (ICU).

Who can participate in this study?

If you are 18 or older, currently in the ICU, and being treated with meropenem or cefepime for a serious antibiotic-resistant infection, you may be able to participate.

What will I need to do as a participant in this study?

If you take part in this study, you agree to:

  • Be enrolled for about 4 days while in the ICU.
  • Receive 2 small IV injections of an FDA-approved kidney function dye (iohexol).
  • Have several small blood draws over 2 days.
  • Share basic health and medical record information.
Will I be compensated for participating in this study?

There will be no cost or charges to you for taking part in this study.

You will be reimbursed $36.00 for each completed study visit for your expenses related to your participation (parking, gas, and time). If you complete all of the study visits, you will be paid a total of $504.00. If you don’t complete all study visits, you will be paid for the visits that you do complete. You will be paid in the form of paper check.

This study is registered on ClinicalTrials.gov under the identifier NCT06709521.

RESTORATIVE303
Join a trial that is testing whether a new treatment (VE303) can be safely used to lower the chances of C. difficile infection coming back after antibiotics.
What is the purpose of the study?

The purpose of this study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. VE303 is an investigational drug that has 8 strains of live bacteria. “Investigational” means that VE303 is not approved for use in people diagnosed with CDI by the United States Food and Drug Administration (FDA), European Medicines Agency (EMA), or any other regulatory authorities. However, the regulatory authorities in your country and an Institutional Review Board have reviewed the study plan and approved the study to be conducted at this study site.

The bacteria strains in VE303 are called “commensals.” Commensals are the type of bacteria that live in harmony with your body, without harming health. These specific bacteria are often found in the intestines of normal, healthy people. They were selected for inclusion in VE303 because they rarely infect humans (mostly in very weakened patients), they do not carry any toxins that can make you sick, and they are not known to carry any risk of creating or spreading resistance to antibiotics.

Approximately 100 people have received VE303 in prior research studies. To date, VE303 has been well tolerated.

In a completed study that included 79 participants with CDI who were at high risk for developing another episode of CDI, VE303 reduced the odds of having a recurrence by over 80 percent. The current study is being conducted to evaluate VE303 in a larger population, to help confirm whether it is safe and effective for the intended use.

Who can participate in this study?

If you are 18 or older, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months. 

What will I need to do as a participant in this study?

If you take part in this study, you agree to:

  • Be in the study for about 6.5 months, starting with a 10–21 day screening period while on antibiotics before your first study dose.
  • Attend 7 clinic visits and 4 phone/telemedicine visits (some may be at-home if available).
  • Provide stool samples on certain days and if your infection comes back.
  • Have blood draws during the study (about 20 tablespoons total, no more than 4 tablespoons in one day).
  • Record daily information in an electronic diary (eDiary), including study drug doses and any symptoms. A device or app will be provided if needed, and paper diaries are allowed if the eDiary cannot be used.
Will I be compensated for participating in this study?

There will be no cost or charges to you for taking part in this study.

You may be reimbursed for any reasonable travel, parking, meals, and other expenses associated with the study visits. You will be reimbursed following each completed visit. During the Double-Blind stage, you will be reimbursed $99.00 or $51.00 (depending on visit) for each in-person clinic visit for your time. You will not be reimbursed for follow-up telephone calls. If you complete all of the in-person visits, you will be reimbursed a total of $2,355.00 for your time and travel. If you do not complete all of the in-person visits, you will be reimbursed for the visits that you do complete.

This study is registered on ClinicalTrials.gov under the identifier NCT06237452.

Our Team

ID-CORE is comprised of caring physicians and researchers with extensive experience in translating knowledge to the patient bedside, developing new treatments, and improving patient care.

If you’re looking for volunteer opportunities or internships, consider ID-CORE. Start by learning more about us and what we do!