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NCT06709521 · ClinicalTrials.gov registry record · Phase 4
Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI)
A Phase 4 study of Bacterial Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 10
- Study locations
NCT06709521: Recruiting Phase 4 study of Bacterial Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06709521 is a Phase 4 study of Bacterial Infection that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 150 participants, above the 87-participant average among 8 other Bacterial Infection trials with a reported enrollment target (72% higher). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06709521, a Phase 4 study of Bacterial Infection, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 10
- Study locations
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 |
What NCT06709521 shows while recruiting
NCT06709521 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 87-participant average among 8 other Bacterial Infection trials with a reported enrollment target (72% higher).
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.
NCT06709521 lists 10 locations in 7 states (California, Michigan, North Carolina).
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.
What interventions are being tested in trial NCT06709521?
The interventions under investigation include: Iohexol (DRUG).
Who is sponsoring clinical trial NCT06709521?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06709521's enrollment target sits among peer trials
150 2nd of 8 higher than 6 of 8 other Bacterial Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bacterial Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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