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

Bacterial Infections Clinical Trial

Official title:

Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Multiple-Model Bayesian Adaptive Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932034
• Other study ID #: LACUSC-Van-01
• Secondary ID: R01GM068968
• Status: Completed
• Phase: N/A
• First received: August 6, 2013
• Last updated: February 16, 2018
• Start date: September 2012
• Est. completion date: July 4, 2016

Study information

• Verified date: February 2018
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: July 4, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Los Angeles County - University of Southern California Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to therapeutic vancomycin blood concentration		Within first week of dosing
Secondary	Number of blood samples sent for vancomycin concentration measurement		Duration of therapy, an average of 10 days in the hospital
Secondary	Incidence of nephrotoxicity	Defined as >0.5 mg/dL or >50% rise from baseline serum creatinine	Duration of therapy, an average of 10 days in the hospital