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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Children's Hospital Los Angeles
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Neely, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT01932034
First received: August 6, 2013
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Bacterial Infections
Device: BestDose Computer Software
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Multiple-Model Bayesian Adaptive Control

Resource links provided by NLM:


Further study details as provided by Children's Hospital Los Angeles:

Primary Outcome Measures:
  • Time to therapeutic vancomycin blood concentration [ Time Frame: Within first week of dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of blood samples sent for vancomycin concentration measurement [ Time Frame: Duration of therapy, an average of 10 days in the hospital ] [ Designated as safety issue: No ]
  • Incidence of nephrotoxicity [ Time Frame: Duration of therapy, an average of 10 days in the hospital ] [ Designated as safety issue: Yes ]
    Defined as >0.5 mg/dL or >50% rise from baseline serum creatinine


Estimated Enrollment: 270
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard dosing
Vancomycin dosed and monitored according to standard practice
Experimental: BestDose Computer Software
Vancomycin dosed using BestDose computer software, targeting AUC rather than trough concentrations
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.
Experimental: 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
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.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932034

Locations
United States, California
Los Angeles County - University of Southern California Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Brenda Jones, MD    323-223-2340    bejones@usc.edu   
Principal Investigator: Brenda Jones, MD         
Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
Principal Investigator: Michael Neely, MD Children's Hospital Los Angeles
  More Information

No publications provided

Responsible Party: Michael Neely, Michael Neely, MD, MSc, FCP, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT01932034     History of Changes
Other Study ID Numbers: LACUSC-Van-01, R01GM068968
Study First Received: August 6, 2013
Last Updated: August 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Los Angeles:
Vancomycin
Pharmacokinetics
Pharmacodynamics
Decision support

Additional relevant MeSH terms:
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014