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NCT07084129 | RECRUITING | Sepsis

Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention
Sponsor:

Children's Hospital of Philadelphia

Brief Summary:

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: 1. Is it feasible to use personalized models of vancomycin dosing in children with sepsis? 2. Will personalized models of vancomycin dosing achieve vancomycin blood levels in acceptable ranges?

Condition or disease

Sepsis

Intervention/treatment

personalized dosing adjustment of vancomycin

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Vancomycin and Acute Kidney Injury in Sepsis Treatment - Pharmacologic Modeling Intervention
Actual Study Start Date : 2025-12
Estimated Primary Completion Date : 2026-08-15
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Month to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention

Location Details

NCT07084129

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How to Participate

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Locations

RECRUITING

United States, Pennsylvania

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104