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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK119463 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this clinical trial is to determine if vancomycin dosing in children with sepsis can be improved by using updated, personalized dosing models that account for new markers of an individual's kidney function. Vancomycin is prescribed based on the known information of how the body breaks this medicine down. Vancomycin may not be effective if blood levels of the medicine are too low. Vancomycin has potential side effects, including the possibility of injury to the kidney. These side effects usually happen when blood levels of vancomycin are too high. There are guidelines for the range of vancomycin blood levels doctors should target to treat an infection and lower the risk of side effects. Children with sepsis may metabolize vancomycin at different rates, faster or slower, than children who do not have sepsis. For these reasons, the current dosing strategy may lead to a higher risk of kidney injury or a risk of not adequately treating an infection in children with sepsis. The investigators' goal is to use new vancomycin dosing equations to improve the ability to select the right dose of vancomycin. The main questions this trial aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized vancomycin Pharmacokinetic model for dose adjustments | Experimental | Enrolled patients who are prescribed vancomycin by the clinical team will transition to the study-determined empiric vancomycin dosing at the time of enrollment, 12mg/kg/dose administered as an extended intravenous (IV) infusion over 2 hours given every 6 hours. Urinary neutrophil gelatinase-associated lipocalin (NGAL) will be measured as soon as possible after enrollment. Dosage adjustments will be made using the personalized vancomycin pharmacokinetic (PK) model incorporating the NGAL level once resulted. Daily urinary NGAL will be measured while on vancomycin therapy and in the intensive care unit (ICU) to evaluate for ongoing changes in renal function that may necessitate further dosage adjustments using the personalized vancomycin PK model, until clinically stabilized. Patients will undergo vancomycin area under the curve (AUC) monitoring with three timed blood draws for vancomycin concentrations with each vancomycin dosing change with a goal AUC target range of 400-600. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| personalized dosing adjustment of vancomycin | Other | A personalized vancomycin PK model that incorporates kidney injury biomarkers will be used for vancomycin dose adjustments to achieve goal AUC levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - personalized dose adjustment performed | Percentage of enrolled patients in which urinary neutrophil gelatinase-associated lipocalin is measured and used to make a vancomycin dosing recommendation | From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Use of study-determined empiric vancomycin dosing | Percentage of patients transitioned to the study-determined empiric vancomycin dosing. | From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment |
| Feasibility - Area under the curve sampling attainment on study empiric vancomycin dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Fitzgerald, MD PhD | Contact | 215-590-4879 | fitzgeraldj@chop.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
all individual participant data (IPD) that underlie results in a publication
Starting 6 months after publication
De-identified IPD and supporting information will be shared upon request and review by the primary investigator. A data use agreement will need to be in place prior to sharing data.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Percentage of patients transitioned to the study-determined empiric vancomycin dosing and undergo subsequent area under the curve sampling. |
| From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment |
| Feasibility - Dosing change based on urinary neutrophil gelatinase-associated lipocalin level | Percentage of patients enrolled in which urinary neutrophil gelatinase-associated lipocalin is used to make a dosing recommendation and results in administration of at least one adjusted dose of vancomycin. | From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment |
| Feasibility - Area under the curve sampling attainment after personalized dose adjustment | Percentage of patients who undergo dose adjustment and have subsequent area under the curve sampling performed | From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment |
| Efficacy and safety - area under the curve in goal range | Percentage of patients achieving area under the curve in goal range of 400-600mg-h/L. | From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment |
| Efficacy and safety - resolution of gram positive infection | Percentage of patients with resolution of gram positive infection within the standard antibiotic duration for the infectious etiology. | From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment |
| Efficacy and safety - development of acute kidney injury | Percentage of patients who develop acute kidney injury during the intervention. | From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment |
| Efficacy and safety - treatment failure | Percentage of patients with treatment failure. | From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |