Clinical trial NCT02269969: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Burns
Infection
Keywords: Aminoglycoside
Pharmacokinetics
Once daily dosing
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Proportion of patients able to achieve therapeutic target
timeFrame: 24 hours
measure: Clearance of tobramycin in the burn population
timeFrame: 24 hours
measure: Volume of distribution of tobramycin in the burn population
timeFrame: 24 hours
measure: Breakpoint in tobramycin clearance based on time post-burn, body burn surface area, inhalation injury score, or percentage of open wounds
timeFrame: 24 hours
measure: Breakpoint in tobramycin volume of distribution based on time post-burn, body burn surface area, inhalation injury score, or percentage of open wounds
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References: