Dose Enhancement of Vancomycin IN Everyday Patients

NCT01427842 | Unknown Phase 2

• 1 other identifier: ETH.4.11.076
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Trough concentration; Vancomycin; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Trough vancomycin concentration

  The primary outcome measure will be the trough serum vancomycin concentration measured at steady state usually between 36 and 60 hours after the initial dose of vancomycin. This according to Australian targets is between 12-18mg/L.

  At steady state for vancomycin received between 36 and 60 hours after the initial dose of vancomycin

Study Arms (1)

DEVINE vancomycin regimen

EXPERIMENTAL

This is the intervention arm and will be the pharmacokinetically derived vancomycin dosing regimen.

Drug: DEVINE vancomycin regimen

Interventions

DEVINE vancomycin regimen DRUG

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.

Also known as: Pharmacokinetically derived vancomycin dosing regimen, Pharmacokinetic vancomycin regimen

DEVINE vancomycin regimen

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients in general wards requiring routine treatment with vancomycin

You may not qualify if:

• GFR \< 30mL/min(as measured by Cockcroft Gault equation)
• Age \< 16 yrs
• Weight \> 200kg
• Patients dosing with Vancomycin other than BD according to national guidelines (ie continuous infusions, q6h etc)
• Vancomycin infused at a rate other than 500mL/min

Sponsors & Collaborators

• The Canberra Hospital: lead

Study Sites (1)

The Canberra Hospital

Canberra, Australian Capital Territory, 2605, Australia

RECRUITING

Study Officials

• Kathryn Daveson, Bsc, MBBS, MPH

  The Canberra Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Daveson, BSc, MBBS, MPH

CONTACT

+61 2 6244 2222; kdavesonwork@hotmail.com

Karlee Johnston, B. Pharm

CONTACT

+61 2 6244 2222; Karlee.Johnston@act.gov.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Kathryn Daveson

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 2, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 2, 2011

Record last verified: 2011-08

Locations

AU (1)