Actively Recruiting
Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention
Led by Children's Hospital of Philadelphia · Updated on 2026-01-12
20
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 1 month and less than 18 years
- Weight greater than 5 kg and less than 50 kg
- Planned vancomycin therapy lasting 48 hours or more
- Admitted to intensive care unit with suspected or confirmed sepsis
- Presence of sepsis-induced respiratory dysfunction (invasive mechanical ventilation) or cardiovascular dysfunction (vasoactive infusion) as part of organ dysfunction, which may be improving or resolved at enrollment
You will not qualify if you...
- Elevated serum creatinine meeting criteria for trough-based dosing by local Clinical Pharmacy
- Methicillin resistant Staph aureus minimum inhibitory concentration (MIC) greater than 1
- Central nervous system infection
- Receiving extracorporeal support such as extracorporeal membrane oxygenation or continuous renal replacement therapy
- Pregnancy
- Chronic dialysis therapy
- Known history of delayed vancomycin clearance based on local pharmacy records
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
J
Julie Fitzgerald, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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