Recruiting
Phase 1

Vancomycin

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT07084129

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

personalized dosing adjustment of vancomycin

Study Details

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?

Conditions

Sepsis

Study ID

NCT07084129

Start date

Apr 15, 2026

Status verified date

May, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Personalized vancomycin Pharmacokinetic model for dose adjustments

Enrolled patients who are prescribed vancomycin by the clinical team will transition to the study-determined empiric vancomycin dosing at the time of enrollment, 12mg/kg/dose administered as an extended intravenous (IV) infusion over 2 hours given every 6 hours. Urinary neutrophil gelatinase-associated lipocalin (NGAL) will be measured as soon as possible after enrollment. Dosage adjustments will be made using the personalized vancomycin pharmacokinetic (PK) model incorporating the NGAL level once resulted. Daily urinary NGAL will be measured while on vancomycin therapy and in the intensive care unit (ICU) to evaluate for ongoing changes in renal function that may necessitate further dosage adjustments using the personalized vancomycin PK model, until clinically stabilized. Patients will undergo vancomycin area under the curve (AUC) monitoring with three timed blood draws for vancomycin concentrations with each vancomycin dosing change with a goal AUC target range of 400-600.

Interventions

personalized dosing adjustment of vancomycin

A personalized vancomycin PK model that incorporates kidney injury biomarkers will be used for vancomycin dose adjustments to achieve goal AUC levels.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Julie Fitzgerald, MD PhD

215-590-4879fitzgeraldj@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Alanah McKelvey

215-590-1000mckelveya@chop.edu

Principal Investigator:

Julie Fitzgerald, MD PhD

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • sepsis
  • vancomycin
  • biomarker
  • pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-05-18.