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Pharmacokinetic Dosing Tool

Computerized Dosing Tool for Bacterial Infections in Children

N/A

Waitlist Available

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized neonates, infants, children, adolescents who require, but have not been initiated on intravenous vancomycin therapy

Hospitalized infants and children from postmenstrual age of 38 weeks to age 19 years requiring IV vancomycin, regardless of indication

Must not have

Will only receive a single dose of vancomycin

On oral or intraperitoneal vancomycin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-6 hours post first dose

Awards & highlights

No Placebo-Only Group

Summary

This trialwill study the best dose of an antibiotic for kids, using a computer decision support tool and comparing results to previous cases.

Who is the study for?

This trial is for hospitalized newborns to teenagers up to 19 years old who need IV vancomycin but haven't started treatment. They must not have taken vancomycin in the last two weeks, don't have end-stage kidney disease or are on dialysis, and aren't pregnant or brain dead. Consent from a parent or guardian is required.

What is being tested?

The study tests a new computer tool called Lyv that helps doctors decide how much vancomycin kids should get based on their body's response to the drug. The results will be compared with past data from similar patients who didn’t use this tool.

What are the potential side effects?

While the side effects are not directly stated for this trial, common side effects of IV vancomycin can include irritation at the injection site, allergic reactions, kidney problems, hearing issues, and blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child needs but hasn't started IV vancomycin treatment.

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My child, aged 0-19 years, needs IV vancomycin in the hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I will receive only one dose of vancomycin.

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I am currently taking vancomycin orally or through injection into the abdomen.

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I am on dialysis or continuous renal replacement therapy for end-stage kidney disease.

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I am undergoing a treatment that involves filtering my blood outside my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-6 hours post first dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-6 hours post first dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-6 hours post first dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC24/MIC target attainment of vancomycin after first dose using the clinical decision support tool compared to dosing using the current hospital method

Secondary study objectives

Vancomycin

To evaluate the accuracy of the clinical decision support system in predicting the AUC24/MIC

To evaluate the incidence of nephrotoxicity for dosing vancomycin using the decision support tool compared to dosing using the current hospital method

Other study objectives

The number of dose changes before getting to the therapeutic dose, defined as the dose achieving AUC24/MIC > 400

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Matched Historical ControlsExperimental Treatment1 Intervention

Match historical controls are patients that were on IV vancomycin with dose adjustments based on vancomycin trough levels. Patients in this study arm will be retrospective patients that will be matched with the intervention group.

Group II: Intervention Group- Computer Decision Support ToolExperimental Treatment1 Intervention

Patients enrolled in the study will be started on IV vancomycin which will be dosed based on the LYV CDS tool, which will dose patients based on AUC24/MIC. Dosing will be adjusted based on vancomycin levels that will be drawn throughout the hospital stay. All patients prospectively enrolled into this study will be in the intervention group. Results will be compared to the retrospectively matched historical controls.

0 / 6Eligibility criteria met