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New treatment option for Bacterial Infection
Official title Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI)
ClinicalTrials.gov ID: NCT06709521
What this study is testing
What is Iohexol?
Iohexol is an investigational medicine, being studied as a potential treatment for bacterial infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 4, interventional, multi-center pharmacokinetics (PK) study in up to 200 adult patients who are residing in an ICU. This study will compare the abilities of Cystatin C (CysC) and CysC-based estimated Glomerular Filtration Rate (eGFR) equations to characterize the PK profiles of meropenem and cefepime relative to Serum Creatinine (SCR), Serum Creatinine based Equation (SCRE), and iohexol in critically ill patients with suspected or documented AMR Gram-negative infections.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>/=18 years at the time of enrollment.
- Residing in an ICU.
- Documented or suspected Antimicrobial Resistant (AMR) Gram-negative infection for which the prospective participant is receiving meropenem or...
- Expectation that the prospective participant will reside in the ICU and receive meropenem or cefepime for the duration of the study, and that all...
- Expectation that IV access will be sufficient for drug infusion and either IV or arterial access will be sufficient to allow for all...
You likely can't join if
- Prospective participant has a documented hypersensitivity or allergic reaction to iohexol, any contrast agents, or iodine.
- Prospective participant has a documented prior history of severe cutaneous reactions to iohexol, any contrast agents, or iodine.
- Prospective participant received iohexol on the calendar day of enrollment or the expectation that they will receive iohexol for clinical care (i.e...
- Prospective participant had a major surgery within one calendar day prior to enrollment.
- Prospective participant had a recent (within 6 months) burn involving \> 25% of total body surface area.
- Prospective participant had a penetrating injury within one calendar day prior to enrollment.
See the full eligibility criteria
- Age \>/=18 years at the time of enrollment.
- Residing in an ICU.
- 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.
- 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.
- 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.
- The prospective participant, or their legally authorized representative (LAR), is able and willing to provide signed informed consent
- Prospective participant has a documented hypersensitivity or allergic reaction to iohexol, any contrast agents, or iodine.
- Prospective participant has a documented prior history of severe cutaneous reactions to iohexol, any contrast agents, or iodine.
- 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.
- Prospective participant had a major surgery within one calendar day prior to enrollment.
- Prospective participant had a recent (within 6 months) burn involving \> 25% of total body surface area.
- Prospective participant had a penetrating injury within one calendar day prior to enrollment.
- 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.
- 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.
- Prospective participant has documented severe thyrotoxicosis as noted in medical records during screening.
- Prospective participant is homozygous for sickle cell disease as noted in medical history/records.
- Prospective participant has a documented diagnosis of hepatorenal syndrome as noted in medical records during screening.
- 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
- Prospective participant is pregnant or breastfeeding.
- Prospective participant received or is expected to receive albumin from one calendar day prior to enrollment to end of study period.
- 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.
- Any condition that, in the judgment of the investigator, precludes participation because it could affect the prospective participant's safety.
The study team makes the final eligibility decision.
Where it's taking place
- Torrance, California, United States
- Detroit, Michigan, United States
- Royal Oak, Michigan, United States
- Durham, North Carolina, United States
- Greenville, North Carolina, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Roanoke, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Torrance, California, United States; Detroit, Michigan, United States; Royal Oak, Michigan, United States; Durham, North Carolina, United States; Greenville, North Carolina, United States; Cincinnati, Ohio, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.