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

NCT ID: NCT02269969

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Burns Infection

Keywords

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Aminoglycoside Pharmacokinetics Once daily dosing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Once daily aminoglycoside

Once daily dosing of Tobramycin

Group Type EXPERIMENTAL

Tobramycin

Intervention Type DRUG

Interventions

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Tobramycin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sandra Walker

OTHER

Sponsor Role lead

Responsible Party

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Sandra Walker

Clinician Scientist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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183-2014

Identifier Type: -

Identifier Source: org_study_id