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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269969
• Other study ID #: 183-2014
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 8, 2014
• Last updated: December 10, 2015
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Burns
• Infection

Intervention

Drug:
• Tobramycin

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sandra Walker

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients able to achieve therapeutic target		24 hours	No
Primary	Clearance of tobramycin in the burn population		24 hours	No
Primary	Volume of distribution of tobramycin in the burn population		24 hours	No
Primary	Breakpoint in tobramycin clearance based on time post-burn, body burn surface area, inhalation injury score, or percentage of open wounds		24 hours	No
Primary	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	No