Computerized Dosing Tool for Bacterial Infections in Children
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve the administration of intravenous vancomycin, an antibiotic, to children with bacterial infections. The focus is on a new computer tool, called Lyv, which helps determine the optimal dose for each child based on individual needs. The trial compares children using this tool to past cases where doses were adjusted by older methods. It is suitable for children who are hospitalized and require IV vancomycin for the first time during their stay. As an unphased trial, this study offers participants a unique opportunity to contribute to advancements in personalized medicine for children.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants should not have received vancomycin in the previous two weeks.
What prior data suggests that the Lyv computerized dosing tool is safe for pediatric patients?
Research has shown that using a computerized tool like Lyv to determine the right dose of vancomycin for children is a new and promising method. However, specific information about the safety of the Lyv tool itself is not yet available. This study is labeled as "Not Applicable" for its phase, likely indicating a focus on determining correct dosing rather than testing safety.
Vancomycin, a well-known antibiotic used in hospitals, is generally safe when used correctly. Incorrect dosing, however, can lead to side effects such as kidney problems. The Lyv tool aims to improve dosing accuracy by adjusting to each patient's needs.
As the Lyv tool is new, extensive safety data may not yet be available. Nonetheless, its inclusion in a study suggests researchers see potential in it. Safety will be carefully monitored during the study. If the Lyv tool aids in dosing without increasing side effects, it could become a valuable addition to current treatment methods.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it introduces a computerized decision support tool to optimize dosing for bacterial infections in children. Unlike traditional methods that adjust doses based on vancomycin trough levels, this tool uses the AUC24/MIC ratio to determine the appropriate dosing of IV vancomycin. This approach aims to improve precision in medication dosages, potentially enhancing treatment effectiveness and minimizing side effects. By refining how vancomycin is administered, the tool could lead to more personalized and effective care for pediatric patients.
What evidence suggests that the Lyv computerized dosing tool is effective for bacterial infections in children?
Research has shown that computerized tools like Lyv, which participants in this trial will use, can help patients reach optimal antibiotic levels more quickly. One study found that this software speeds up the process of achieving these target levels, potentially leading to better outcomes for patients with serious infections. For children with bacterial infections, this means more accurate dosing of vancomycin, which might result in fewer side effects and improved treatment results. Although more research is needed, early findings are promising for using these tools to enhance antibiotic treatment in children.678910
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive individualized vancomycin dosing based on the Clinical Decision Support tool for up to 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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 Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
Center for Translational Medicine at the School of Pharmacy
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
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