Computerized Dosing Tool for Bacterial Infections in Children

Overseen By Siddhartha A Dante, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: Intravenous vancomycin

Must not be taking: Oral vancomycin

Disqualifiers: Renal disease, Pregnant, Brain death, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the pharmacokinetic and pharmacodynamic dosing properties of intravenous vancomycin in pediatric patients using a novel computer decision support (CDS) tool called Lyv. Dosing will be individualized based on AUC24/MIC. The results will be compared to matched historical controls.

Eligibility Criteria

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.

Inclusion Criteria

Parent or legally authorized representative is willing to provide permission and sign the informed consent document; subjects assent, when appropriate

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

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

Exclusion Criteria

I have taken vancomycin in the last 2 weeks.

I will receive only one dose of vancomycin.

Known to be pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

Treatment

Participants receive individualized vancomycin dosing based on the Clinical Decision Support tool for up to 7 days

7 days

Daily monitoring and dose adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Lyv

Trial Overview 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.

Participant Groups

Group I: Matched Historical Controls Experimental Treatment 1 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 Tool Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Center for Translational Medicine at the School of Pharmacy

Collaborator

Trials

1

Recruited

80+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+