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Pharmacokinetic Dosing Tool

Computerized Dosing Tool for Bacterial Infections in Children

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-6 hours post first dose
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My child needs but hasn't started IV vancomycin treatment.
Select...
My child, aged 0-19 years, needs IV vancomycin in the hospital.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC24/MIC target attainment of vancomycin after first dose using the clinical decision support tool compared to dosing using the current hospital method
Secondary outcome measures
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 outcome measures
The number of dose changes before getting to the therapeutic dose, defined as the dose achieving AUC24/MIC > 400

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.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
685 Previous Clinical Trials
373,021 Total Patients Enrolled
Center for Translational Medicine at the School of PharmacyUNKNOWN
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,956 Previous Clinical Trials
2,672,145 Total Patients Enrolled

Media Library

Lyv (Pharmacokinetic Dosing Tool) Clinical Trial Eligibility Overview. Trial Name: NCT04911270 — N/A
Bacterial Infection Research Study Groups: Intervention Group- Computer Decision Support Tool, Matched Historical Controls
Bacterial Infection Clinical Trial 2023: Lyv Highlights & Side Effects. Trial Name: NCT04911270 — N/A
Lyv (Pharmacokinetic Dosing Tool) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04911270 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research opportunity still available to participants?

"Affirmative. Clinicaltrials.gov data confirms that this clinical trial is presently recruiting from 1 medical centre and searching for 75 patients to participate in the study, which was initially posted on May 9th 2022."

Answered by AI

How many individuals are enrolled in the experiment?

"Affirmative. According to the clinicaltrials.gov website, recruitment for this trial is currently in progress since it was first posted on May 9th 2022. Last updated on October 10th 2022, the study requires 75 participants from a single site."

Answered by AI
~9 spots leftby Jul 2024