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Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI)
NCT06709521 · View on ClinicalTrials.gov ↗
Study Summary
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 AMR Gram-negative infections. We hypothesize that CysC and CysC-based eGFR equations will characterize the PK profiles of meropenem and cefepime at the population and individual levels with greater accuracy and precision than SCR and SCREs. Iohexol will be administered to patients enrolled in the study and serve as the reference indicator of measured Glomerular Filtration Rate (mGFR), which is the gold standard assessment of kidney function. We hypothesize that the predictive performances of CysC and CysC-based eGFR equations in estimating the PK profiles of meropenem and cefepime at the population and individual levels will be comparable to iohexol. The information obtained in this study will be used to develop PK/pharmacodynamics (PD) optimized meropenem and cefepime dosing schemes based on the renal function biomarker population PK (PopPK) model with the best predictive performance for clinical use in the treatment of critically ill adult patients with suspected or documented AMR Gram-negative infections and varying degrees of renal function. The primary objective of this study is to compare the abilities of renal function biomarkers (CysC, CysC-based eGFR equations, SCR, SCREs) relative to iohexol to characterize the PK profiles of meropenem and cefepime in critically ill adult patients with suspected or documented AMR Gram-negative infections.
Conditions Studied
Interventions
- DRUG Iohexol
Study Locations (10)
California
- Harbor UCLA Medical Center - Medicine - Infectious Diseases — Torrance
- Torrance Memorial Medical Center — Torrance
Michigan
- Henry Ford Health System - Henry Ford Hospital — Detroit
- Corewell Health - Infectious Disease — Royal Oak
North Carolina
- Duke University Hospital - Infectious Diseases — Durham
- East Carolina University - Infectious Diseases and Tropical/Travel Medicine Clinic — Greenville
Ohio
- University of Cincinnati College of Medicine - Division of Infectious Diseases — Cincinnati
Oregon
- Oregon Health and Science University - Adult Infectious Diseases Clinic — Portland
Pennsylvania
- University of Pittsburgh - Medicine - Infectious Diseases — Pittsburgh
Virginia
- Carilion Roanoke Memorial Hospital — Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-02-12 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06709521
The ClinicalTrials.gov registry entry for NCT06709521 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Bacterial Infection appearing as the primary indexed condition, and to 1 intervention — of which Iohexol is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06709521 reports 10 study locations spanning 7 distinct geographic areas — top geographies include California, Michigan, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06709521 about?
NCT06709521 is a clinical study titled "Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI)". 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 ...
What is the current status of trial NCT06709521?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2025-02-12. Estimated completion is 2026-10-30.
What conditions does trial NCT06709521 study?
This clinical trial studies the following conditions: Bacterial Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06709521?
The interventions under investigation include: Iohexol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06709521?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06709521 being conducted?
This trial has 10 study locations across California, Michigan, North Carolina, Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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