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Can a simple kidney test help beat superbugs in the ICU?
NCT ID NCT06709521
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 5 times
Summary
This study aims to see if using a blood marker called Cystatin C can better predict how antibiotics work in critically ill ICU patients with drug-resistant infections. Researchers will compare Cystatin C to standard kidney function tests and a dye-based gold-standard test. The goal is to design dosing plans that are more accurate for each patient, potentially improving treatment success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Iohexol (a contrast dye used to measure kidney function), meropenem, cefepime
- What this could lead to
- If successful, this could lead to more precise antibiotic dosing for ICU patients, potentially improving treatment of resistant infections and reducing side effects.
- What could go wrong
- This is a Phase 4 study focused on measuring and modeling drug levels, not testing a new treatment. It may not directly improve patient outcomes, and results may not apply to all ICU settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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161 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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Jul 2026
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age \>/=18 years at the time of enrollment. 2. Residing in an ICU. 3. Documented or suspected Antimicrobial Resistant (AMR) Gram-negative infection for which the prospective participant is receiving meropenem or cefepime as part of their clinical management. 4. 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. 5. Expectation that IV access will be sufficient for drug infusion and either IV or arterial access will be sufficient to allow for all protocol-required blood sampling to occur. 6. The prospective participant, or their legally authorized representative (LAR), is able and willing to provide signed informed consent Exclusion Criteria: 1. Prospective participant has a documented hypersensitivity or allergic reaction to iohexol, any contrast agents, or iodine. 2. Prospective participant has a documented prior history of severe cutaneous reactions to iohexol, any contrast agents, or iodine. 3. Prospective participant received iohexol on the calendar day of enrollment or the expectation that they will receive iohexol for clinical care (i.e., Standard of Care \[SOC\]) during the study. 4. Prospective participant had a major surgery within one calendar day prior to enrollment. 5. Prospective participant had a recent (within 6 months) burn involving \> 25% of total body surface area. 6. Prospective participant had a penetrating injury within one calendar day prior to enrollment. 7. Prospective participant is currently receiving or is expected to receive any type of renal replacement therapy including hemodialysis or extra corporeal membrane oxygenation, during study period. 8. Prospective participant has a documented diagnosis of diabetes with a serum creatinine (SCR) obtained for clinical care purposes (i.e., SOC results) \>3 mg/dL during screening. 9. Prospective participant has documented severe thyrotoxicosis as noted in medical records during screening. 10. Prospective participant is homozygous for sickle cell disease as noted in medical history/records. 11. Prospective participant has a documented diagnosis of hepatorenal syndrome as noted in medical records during screening. 12. Prospective participant is anuric\* for \>/ = 1 calendar day during screening AND has any one of the following documented conditions as noted in medical history/records: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
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Corewell Health - Infectious Disease
Royal Oak, Michigan, 48073, United States
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Duke University Hospital - Infectious Diseases
Durham, North Carolina, 27710, United States
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East Carolina University - Infectious Diseases and Tropical/Travel Medicine Clinic
Greenville, North Carolina, 27834-9997, United States
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Harbor UCLA Medical Center - Medicine - Infectious Diseases
Torrance, California, 90502-2006, United States
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Henry Ford Health System - Henry Ford Hospital
Detroit, Michigan, 48202-2608, United States
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Oregon Health and Science University - Adult Infectious Diseases Clinic
Portland, Oregon, 97239-3098, United States
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Torrance Memorial Medical Center
Torrance, California, 90505, United States
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University of Cincinnati College of Medicine - Division of Infectious Diseases
Cincinnati, Ohio, 45267, United States
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University of Pittsburgh - Medicine - Infectious Diseases
Pittsburgh, Pennsylvania, 15213-3403, United States
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