Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention

NCT07084129 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 24-022663K23DK119463
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Sepsis

Keywords

sepsis; vancomycin; biomarker; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Feasibility - personalized dose adjustment performed

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

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

Secondary Outcomes (8)

• Feasibility - Use of study-determined empiric vancomycin dosing

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

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

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

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

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

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

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

• Efficacy and safety - area under the curve in goal range

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

Study Arms (1)

Personalized vancomycin Pharmacokinetic model for dose adjustments

EXPERIMENTAL

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.

Other: personalized dosing adjustment of vancomycin

Interventions

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.

Personalized vancomycin Pharmacokinetic model for dose adjustments

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Julie Fitzgerald, MD PhD

CONTACT

215-590-4879; fitzgeraldj@chop.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 24, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: De-identified IPD and supporting information will be shared upon request and review by the primary investigator. A data use agreement will need to be in place prior to sharing data.

Locations

US (1)