Personalized vancomycin dosing to lower kidney injury risk in children with sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial enrolls children older than 1 month and under 18 years admitted to the ICU with suspected or confirmed sepsis who are expected to receive vancomycin for at least 48 hours. Participants receive vancomycin dosing adjusted by individualized pharmacokinetic models that incorporate novel biomarkers of kidney function rather than relying solely on standard creatinine- or weight-based rules. The study monitors vancomycin blood levels, kidney biomarkers, and clinical kidney function to guide dosing and detect acute kidney injury. Conducted at the Children's Hospital of Philadelphia, the trial tracks whether personalized dosing can keep vancomycin in target ranges and lower signs of kidney injury.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Julie Fitzgerald, MD PhD
• Email: fitzgeraldj@chop.edu
• Phone: 215-590-4879

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.