Personalized vancomycin dosing to lower kidney injury risk in children with sepsis
Vancomycin and Acute Kidney Injury in Sepsis Treatment - Pharmacologic Modeling Intervention
This will test whether using updated, personalized kidney-function markers to guide vancomycin dosing helps children with sepsis reach effective drug levels and reduces kidney injury.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 1 Month to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07084129 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged >1 month to <18 years, weighing 5–50 kg, admitted to the ICU with suspected or confirmed sepsis and planned to receive vancomycin for at least 48 hours are the intended participants.
Not a fit: Children on chronic dialysis, receiving extracorporeal support, pregnant patients, those with central nervous system infections, or with known delayed vancomycin clearance are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could improve vancomycin effectiveness while reducing the risk of acute kidney injury in children with sepsis.
How similar studies have performed: Prior adult and limited pediatric work using AUC-guided vancomycin dosing and kidney biomarkers shows promise, but this specific biomarker-driven personalized dosing approach in pediatric sepsis is still relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.