Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software

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.

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.