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NCT Number: NCT07084129

Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention

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?

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Alanah McKelvey

CONTACT

[email protected]

215-590-1000

Julie Fitzgerald, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >1 month and <18 years
  • Weight >5kg and <50kg
  • Vancomycin intended duration of therapy ≥48 hours
  • Admitted to intensive care unit with suspected or confirmed sepsis
  • 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

  • Serum creatinine elevated and meets criteria for trough-based dosing by local Clinical Pharmacy
  • Methicillin resistant Staph aureus minimum inhibitory concentration (MIC)>1
  • Central nervous system infection
  • Extracorporeal support (extracorporeal membrane oxygenation, continuous renal replacement therapy)
  • Pregnancy
  • Patients on chronic dialysis therapy
  • Patients with known history of delayed vancomycin clearance based on local pharmacy records

Treatment and study plan

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.

Primary outcomes

  1. Feasibility - personalized dose adjustment performed

    Time frame: From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment

    Percentage of enrolled patients in which urinary neutrophil gelatinase-associated lipocalin is measured and used to make a vancomycin dosing recommendation

Secondary outcomes

  1. Feasibility - Use of study-determined empiric vancomycin dosing

    Time frame: From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment

    Percentage of patients transitioned to the study-determined empiric vancomycin dosing.

  2. Feasibility - Area under the curve sampling attainment on study empiric vancomycin dosing

    Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment

    Percentage of patients transitioned to the study-determined empiric vancomycin dosing and undergo subsequent area under the curve sampling.

  3. Feasibility - Dosing change based on urinary neutrophil gelatinase-associated lipocalin level

    Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment

    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.

  4. Feasibility - Area under the curve sampling attainment after personalized dose adjustment

    Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment

    Percentage of patients who undergo dose adjustment and have subsequent area under the curve sampling performed

  5. Efficacy and safety - area under the curve in goal range

    Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment

    Percentage of patients achieving area under the curve in goal range of 400-600mg-h/L.

  6. Efficacy and safety - resolution of gram positive infection

    Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment

    Percentage of patients with resolution of gram positive infection within the standard antibiotic duration for the infectious etiology.

  7. Efficacy and safety - development of acute kidney injury

    Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment

    Percentage of patients who develop acute kidney injury during the intervention.

  8. Efficacy and safety - treatment failure

    Time frame: From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment

    Percentage of patients with treatment failure.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Fitzgerald, MD PhD

CONTACT

[email protected]

215-590-4879

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Vancomycin and Acute Kidney Injury in Sepsis Treatment - Pharmacologic Modeling Intervention

Acronym: VAST-i

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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