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Dose Enhancement of Vancomycin IN Everyday Patients

NCT01427842 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-09-02

No results posted yet for this study

Summary

Current Australian guidelines for vancomycin commonly underdoses individuals particularly in the first 48 hours.

The aim of the trial is to compare two dosing regimens; the current Australian guidelines versus a more appropriately modeled pharmacokinetic based regimen with the overall aim of developing a new vancomycin dosing strategy that will enable patients to have more individualised and therapeutically efficacious treatment.

The hypothesis is that dosing vancomycin according to a pharmacokinetically modeled regimen increases the likelihood of achieving therapeutic trough levels of vancomycin within the first 48 hours (or at steady state, whichever is sooner) compared to dosing vancomycin according to the current Antibiotic guidelines.

Conditions

  • Vancomycin Therapy

Interventions

DRUG

DEVINE vancomycin regimen

The dosing regimen varies by weight and height and by initial or ongoing dose prescribed. The loading dose is based on actual volume of distribution of vancomycin whilst the ongoing doses are based on creatinine clearance.

Sponsors & Collaborators

  • The Canberra Hospital

    lead OTHER

Principal Investigators

  • Kathryn Daveson, Bsc, MBBS, MPH · The Canberra Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01427842 on ClinicalTrials.gov