OPTIMIZE-GNI
The purpose of OPTIMIZE-GNI is to evaluate new methods for monitoring 2 medications given to patients with antibiotic-resistant gram-negative bacterial infections.
About This Study
Summary
Although medications like antibiotics are important weapons for fighting illness, they can have unwanted side effects. Clinicians use various tools, including laboratory tests, to monitor whether the treatment a patient receives is both effective and safe for them. For example, two antibiotics used to treat antimicrobial-resistant gram-negative infections (meropenem and cefepime) can decrease kidney function in some patients.
The "gold standard" method for assessing kidney function involves using a marker compound (iohexol), but some patients have allergic reactions to iohexol. As a potential alternative, the OPTIMIZE-GNI study is investigating cystatin (Cys-C), a normal protein produced by cells in the body and released into the bloodstream. The goal of the OPTIMIZE-GNI study is to show that, in terms of estimating kidney function, using Cys-C is at least as accurate as using iohexol. Having accurate information about patients’ kidney function helps physicians to tailor their treatment plans to minimize side effects and maximize therapeutic benefit.
To be included in OPTIMIZE-GNI, participants must be / have
- Adult (18 years or older) ICU patient
- Documented or suspected antimicrobial-resistant gram-negative infection currently being treated with meropenem or cefepime
To be included in OPTIMIZE-GNI, participants must not be / have
- Hypersensitivity or allergic reaction to iohexol, any other contrast agent, or iodine
- Prior history of severe cutaneous reactions to iohexol, any contrast agents, or iodine
- Received iohexol within 1 day prior to enrollment OR expected to receive iohexol for clinical care during the study
- Major surgery within 2 days prior to enrollment
Keywords
Antimicrobial resistance; Gram-negative infection; Kidney function.
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Tasaduq N. Fazili, MD, is an infectious diseases specialist with more than 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.
Official title of study
Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI)
Funding mechanism
Federally funded by National Institute of Allergy and Infectious Diseases (NIAID)