Optimization of Beta-Lactam Dosing in Critically Ill Patients With Suspected or Documented Antimicrobial Resistant Gram-Negative Infections With Cystatin C (OPTIMIZE GNI)
About
The purpose of this study is to evaluate the abilities of Cystatin C (CysC) and CysC-based estimated Glomerular Filtration Rate (eGFR) equations to characterize the pharmacokinetics (PK) profiles of meropenem and cefepime relative to Serum Creatinine (SCR), Serum Creatinine-based Equation (SCRE) and iohexol at the population and individual levels in critically ill adult patients with suspected or documented Antimicrobial Resistant (AMR) Gram-negative infections.
Most antibiotics used in intensive care unit (ICU) patients are mainly cleared by the kidneys, and the ability to dose renally cleared drugs appropriately is challenging in ICU patients due to the wide range of renal disorders encountered in this population. The purpose of this study is to gather data about how the body reacts, processes and eliminates the antibiotics (meropenem or cefepime).
Patients will be enrolled in the study for approximately 4 days following signing of this consent form. Blood will be drawn at different time points following the administration of iohexol. Iohexol is an agent that is routinely used for imaging studies and determining a patient’s kidney function in clinical practice. The blood collected will be used to determine the levels of meropenem or cefepime, iohexol and 2 other common tests that clinicians use to determine kidney function in patients called serum creatinine (SCR) and Cystatin C (CysC). Researchers will use all information collected in this study to develop more accurate dose and dosing frequency for meropenem and cefepime for future ICU patients with different levels of kidney function.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Residing in an ICU
- Documented or suspected AMR Gram-negative infection for which the prospective participant is receiving meropenem or cefepime as part of their clinical management
- Expectation that the prospective participant will reside in the ICU and receive meropenem or cefepime for the duration of the study, and that all study procedures will be completed
- The prospective participant, or their legally authorized representative (LAR), is able and willing to provide signed informed consent
Exclusion Criteria
- Prospective participant has documented hypersensitivity or allergic reaction to iohexol, any contrast agents or iodine
- Prospective participant has documented prior history of severe cutaneous reactions to iohexol, any contrast agents or iodine
- Prospective participant received iohexol within one calendar day prior to enrollment or the expectation that they will receive iohexol for clinical care (i.e., SOC) during the study
- Prospective participant had a major surgery* within 2 calendar days prior to enrollment
- *Major surgery will be defined as "the opening of either a body cavity or the mesenchymal barrier, using general anesthesia"
Primary Investigator
Dr. Tasaduq Fazili is an infectious diseases specialist with over 30 years of clinical experience. He is a professor at the Virginia Tech Carilion School of Medicine. He is a board-certified internal medicine and infectious disease physician. He completed his fellowship at Albany Medical College and completed his internship and residency at State University of New York.
Contact Information
Suhaib Dar, MD
Senior Research Associate
