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

Phase 1

Completed

• Conditions: Burns; Infection
• Interventions: Drug: Tobramycin

• Registration Number: NCT02269969
• Lead Sponsor: Sandra Walker

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-21
• Study Start: 2015-03
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Once daily aminoglycoside	Tobramycin	Once daily dosing of Tobramycin

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada