Overview

This trial is active, not recruiting.

Condition bacterial infections
Treatment bestdose computer software
Phase phase 2
Sponsor Children's Hospital Los Angeles
Collaborator National Institute of General Medical Sciences (NIGMS)
Start date September 2012
End date June 2016
Trial size 263 participants
Trial identifier NCT01932034, LACUSC-Van-01, R01GM068968

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Vancomycin dosed and monitored according to standard practice
(Experimental)
Vancomycin dosed using BestDose computer software, targeting AUC rather than trough concentrations
bestdose computer software
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.
(Experimental)
Vancomycin dosed using BestDose computer software, targeting AUC rather than trough concentrations and with computer-generated suggested optimal blood sampling times
bestdose computer software
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.

Primary Outcomes

Measure
Time to therapeutic vancomycin blood concentration
time frame: Within first week of dosing

Secondary Outcomes

Measure
Number of blood samples sent for vancomycin concentration measurement
time frame: Duration of therapy, an average of 10 days in the hospital
Incidence of nephrotoxicity
time frame: Duration of therapy, an average of 10 days in the hospital

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 1. 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. 2. Participants will of any age. 3. Participant/parent/legal guardian (as applicable) must be able and willing to provide signed informed consent. Exclusion Criteria: 1. 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) 2. Known colonization or infection with a vancomycin resistant organism (MIC > 2 mg/L) 3. Known hypersensitivity or intolerance to vancomycin 4. Patients on any form of dialysis 5. Not expected to survive >72 hours.

Additional Information

Official title Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Multiple-Model Bayesian Adaptive Control
Principal investigator Michael Neely, MD
Description Recent guidelines to use the antibiotic vancomycin for serious, resistant gram-positive bacterial infections advocate higher plasma concentrations than are routinely achieved with conventional dosing. Moreover, there is wide interpatient variability in vancomycin plasma concentrations, even with standardized dosing. The hypothesis for this study is that dosing vancomycin assisted by computer software and Bayesian algorithms will lead to more rapid and accurate attainment of therapeutic blood vancomycin concentrations in children and adults. This study will enroll 90 patients per year for three years, totaling 270 patients. Eligible patients will be of any age and who are to be prescribed vancomycin by their clinicians for medical indications. Patients with vancomycin-resistant organisms, severe vancomycin allergies or who need dialysis will not be eligible. Participants in the first group of 90 will be treated according to standard care. The second and third groups of patients will be dosed with vancomycin according to the recommendations made by the study team using the BestDose software developed by the USC Laboratory of Applied Pharmacokinetics. The second group will be dosed with the software in its current form, and the third group with funded updates. For all groups, no additional blood samples will be drawn for research purposes; only routinely obtained clinical data will be used. The primary outcome in all groups will be the percentage of participants with appropriate vancomycin concentrations. Secondary outcomes in those who receive vancomycin for at least 72 hours will include effectiveness, toxicity rates, and costs of therapy. Participation in the study will cease at the time of hospital discharge or 72 hours after termination of vancomycin therapy.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Children's Hospital Los Angeles.