Back to resultsOnce Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study
Primary Purpose
Burns, Infection
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Tobramycin
Sponsored by
About this trial
This is an interventional basic science trial for Burns focused on measuring Aminoglycoside, Pharmacokinetics, Once daily dosing
Eligibility Criteria
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
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Once daily aminoglycoside
Arm Description
Once daily dosing of Tobramycin
Outcomes
Primary Outcome Measures
Proportion of patients able to achieve therapeutic target
Clearance of tobramycin in the burn population
Volume of distribution of tobramycin in the burn population
Breakpoint in tobramycin clearance based on time post-burn, body burn surface area, inhalation injury score, or percentage of open wounds
Breakpoint in tobramycin volume of distribution based on time post-burn, body burn surface area, inhalation injury score, or percentage of open wounds
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02269969
Brief Title
Once Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study
Official Title
Once Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sandra Walker
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Infection
Keywords
Aminoglycoside, Pharmacokinetics, Once daily dosing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Once daily aminoglycoside
Arm Type
Experimental
Arm Description
Once daily dosing of Tobramycin
Intervention Type
Drug
Intervention Name(s)
Tobramycin
Primary Outcome Measure Information:
Title
Proportion of patients able to achieve therapeutic target
Time Frame
24 hours
Title
Clearance of tobramycin in the burn population
Time Frame
24 hours
Title
Volume of distribution of tobramycin in the burn population
Time Frame
24 hours
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Once Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study
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