RECRUITING

Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

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

Quick Facts

Study Start:2025-09-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07084129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>1 month and \<18 years
  2. 2. Weight \>5kg and \<50kg
  3. 3. Vancomycin intended duration of therapy ≥48 hours
  4. 4. Admitted to intensive care unit with suspected or confirmed sepsis
  5. 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)
  1. 1. Serum creatinine elevated and meets criteria for trough-based dosing by local Clinical Pharmacy
  2. 2. Methicillin resistant Staph aureus minimum inhibitory concentration (MIC)\>1
  3. 3. Central nervous system infection
  4. 4. Extracorporeal support (extracorporeal membrane oxygenation, continuous renal replacement therapy)
  5. 5. Pregnancy
  6. 6. Patients on chronic dialysis therapy
  7. 7. Patients with known history of delayed vancomycin clearance based on local pharmacy records

Contacts and Locations

Study Contact

Julie Fitzgerald, MD PhD
CONTACT
215-590-4879
fitzgeraldj@chop.edu

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-09-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • sepsis
  • vancomycin
  • biomarker
  • pharmacokinetics

Additional Relevant MeSH Terms

  • Sepsis