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

Sandra Walker

Status and phase: Completed; Phase 2; Phase 1

Conditions: Infection; Burns

Treatments: Drug: Tobramycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02269969

183-2014

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Once daily aminoglycoside

Experimental group

Description:

Once daily dosing of Tobramycin

Treatment:

Drug: Tobramycin