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OPTIMIZE-GNI: Beta-lactam Dosing in Critically Ill Patients

This study, called OPTIMIZE-GNI, is looking at how to best give antibiotics like meropenem and cefepime to critically ill patients with bacterial infections that are hard to treat (Antimicrobial Resistant Gram-negative infections). Researchers want to see if using a marker called Cystatin C (CysC) and related kidney function tests can help doctors give the right dose of these antibiotics more accurately than current methods. The study will compare CysC to other kidney function tests, including one using a substance called iohexol, to understand how the body processes these antibiotics. You may be able to join if you are 18 or older, in an ICU, and receiving meropenem or cefepime for a suspected or confirmed difficult-to-treat bacterial infection. The study is currently unclear on its recruitment status.

Study design
This is a Phase 4, interventional study involving up to 200 adult patients in multiple hospitals.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken on Days 1-2 of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06709521

Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI)

Completed
PHASE4Ages 18+InterventionalTreatment
National Institute of Allergy and Infectious Diseases (NIAID)
~161 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Iohexol

At a glance

Recruiting sites
0 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clearance (Cl)
Measured over Days 1-2
+3 more outcomes measured

Conditions

Bacterial Infection

Explore related trials

Bacterial InfectionGram-negative Infection

Where it's being run

10 sites across 7 states
California2
Michigan2
North Carolina2
Ohio1
Oregon1
Pennsylvania1
Virginia1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Pheochromocytoma
Myelomatosis
Multiple myeloma
Paraproteinemia \*Anuria is defined as urine production \<100 mL in a calendar day 13. Prospective participant is pregnant or breastfeeding. 14. Prospective participant received or is expected to receive albumin from one calendar day prior to enrollment to end of study period. 15. Prospective participant received or is expected to receive \>/= 3 units of any blood product other than platelets from one calendar day prior to enrollment to end of study period. 16. Any condition that, in the judgment of the investigator, precludes participation because it could affect the prospective participant's safety.

What this trial measures

  • Clearance (Cl)Days 1-2
  • Composite Euclidean distance scoreDays 1-2

    Summarizes predictive precision, accuracy, and bias of the cefepime or meropenem renal function biomarker population pharmacokinetic (PopPK) model relative to the corresponding iohexol clearance PopPK model using the validation dataset.

  • Intercompartment rate constantDays 1-2
  • Volume of distribution (Vd)Days 1-2