Once Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study

December 10, 2015 updated by: Sandra Walker
Effective antimicrobial use in the burn population is important since this population is at an increased risk for infections during their stay in hospital as a result of their burn injury. Tobramycin is an antibiotic that has activity against common burn wound associated pathogens, such as Pseudomonas Aeruginosa, and its use is becoming increasingly relevant due to the increased incidence of bacterial resistance to currently utilized antibiotics. Once daily dosing of tobramycin has been safely and effectively used in the majority of infected patients for many years with the proposed benefits of optimized antibacterial activity and reduced nephrotoxicity compared to traditional dosing. But, the once daily dosing regimen has yet to be validated in the burn population. The purpose of this study is to validate the plausibility of once daily tobramycin dosing in the burn population with intent to determine a safe, effective, and efficient dosing regimen for this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult burn patient (≥ 18 years old)
  • Total burn surface area less than 20%
  • At least 48 hours after the time of the initial burn injury event
  • Has a suspected or confirmed infection
  • Has been receiving antibiotic therapy for at least 24 hours

Exclusion Criteria:

  • Pediatric patients (< 18 years old);
  • Pregnant
  • Documented history of cochlear or vestibular injury
  • Creatinine clearance < 50 ml/min
  • Requiring any modality of dialysis
  • Has been receiving antibiotic therapy for longer than 72 hours
  • Known allergy or adverse reaction to aminoglycoside antibiotics
  • Known allergy or adverse reaction to sulfites
  • Diagnosis of Parkinson's disease or myasthenia gravis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Once daily aminoglycoside
Once daily dosing of Tobramycin
Drug: Tobramycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients able to achieve therapeutic target
Time Frame: 24 hours
24 hours
Clearance of tobramycin in the burn population
Time Frame: 24 hours
24 hours
Volume of distribution of tobramycin in the burn population
Time Frame: 24 hours
24 hours
Breakpoint in tobramycin clearance based on time post-burn, body burn surface area, inhalation injury score, or percentage of open wounds
Time Frame: 24 hours
24 hours
Breakpoint in tobramycin volume of distribution based on time post-burn, body burn surface area, inhalation injury score, or percentage of open wounds
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandra Walker

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 183-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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