Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software
2 other identifiers
observational
263
1 country
1
Brief Summary
We will compare the percentage of patients having therapeutic vancomycin serum concentrations after current standard dosing, after dosing with our software. We will also include therapeutic outcomes and costs in the analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 6, 2013
CompletedFirst Posted
Study publicly available on registry
August 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2016
CompletedFebruary 20, 2018
February 1, 2018
3.8 years
August 6, 2013
February 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to therapeutic vancomycin blood concentration
Within first week of dosing
Secondary Outcomes (2)
Number of blood samples sent for vancomycin concentration measurement
Duration of therapy, an average of 10 days in the hospital
Incidence of nephrotoxicity
Duration of therapy, an average of 10 days in the hospital
Study Arms (3)
Standard dosing
Vancomycin dosed and monitored according to standard practice
BestDose Computer Software
Vancomycin dosed using BestDose computer software, targeting AUC rather than trough concentrations
BestDose Computer Software 2
Vancomycin dosed using BestDose computer software, targeting AUC rather than trough concentrations and with computer-generated suggested optimal blood sampling times
Interventions
BestDose is made by the USC Laboratory of Applied Pharmacokinetics. It uses a multiple-model, Bayesian adaptive control algorithm to find the maximally precise dose that will achieve a user-specified target concentration or concentrations.
Eligibility Criteria
Hospitalized infants, children, adolescents, and adults who require, but have not started vancomycin therapy for infections with suspected or proven beta-lactam resistant gram-positive bacteria will eligible for enrollment
You may qualify if:
- Hospitalized infants, children, adolescents, and adults who require, but have not started vancomycin therapy for infections with suspected or proven beta-lactam resistant gram-positive bacteria will eligible for enrollment.
- Participants will of any age.
- Participant/parent/legal guardian (as applicable) must be able and willing to provide signed informed consent.
You may not qualify if:
- Prior receipt of vancomycin for the same clinical event (e.g. the same fever of unknown origin in a neutropenic patient defined as \<24 hours of no fever)
- Known colonization or infection with a vancomycin resistant organism (MIC \> 2 mg/L)
- Known hypersensitivity or intolerance to vancomycin
- Patients on any form of dialysis
- Not expected to survive \>72 hours.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Los Angeles County - University of Southern California Medical Center
Los Angeles, California, 90033, United States
Related Publications (1)
Neely MN, Kato L, Youn G, Kraler L, Bayard D, van Guilder M, Schumitzky A, Yamada W, Jones B, Minejima E. Prospective Trial on the Use of Trough Concentration versus Area under the Curve To Determine Therapeutic Vancomycin Dosing. Antimicrob Agents Chemother. 2018 Jan 25;62(2):e02042-17. doi: 10.1128/AAC.02042-17. Print 2018 Feb.
PMID: 29203493DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Neely, MD
Children's Hospital Los Angeles
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Michael Neely, MD, MSc, FCP
Study Record Dates
First Submitted
August 6, 2013
First Posted
August 30, 2013
Study Start
September 1, 2012
Primary Completion
July 1, 2016
Study Completion
July 4, 2016
Last Updated
February 20, 2018
Record last verified: 2018-02