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Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention

RecruitingPhase 1Ages 1 Month - 17 YearsAllChildren's Hospital of Philadelphia
NCT07084129 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ri

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age \>1 month and \<18 years 2. Weight \>5kg and \<50kg 3. Vancomycin intended duration of therapy ≥48 hours 4. Admitted to intensive care unit with suspected or confirmed sepsis 5. Either sepsis-induced respiratory (invasive mechanical ventilation) or cardiovascular (vasoactive infusion) dysfunction as part of sepsis-associated organ dysfunction (these organ dysfunctions may be improving or resolved at the time of enrollment) Exclusion Criteria: 1. Serum creatinine elevated and meets criteria for trough-based dosing by local Clinical Pharmacy 2. Methicillin resistant Staph aureus minimum inhibitory concentration (MIC)\>1 3. Central nervous system infection 4. Extracorporeal support (extracorporeal membrane oxygenation, continuous renal replacement therapy) 5. Pregnancy 6. Patients on chronic dialysis therapy 7. Patients with known history of delayed vancomycin clearance based on local pharmacy records
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What it tests

  • personalized dosing adjustment of vancomycin
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Where

1 site
Children's Hospital of Philadelphia
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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