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Completed

NCT Number: NCT02269969

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

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.

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Key information

Conditions

Burns Infection Infections Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tobramycin

Drug

Primary outcomes

  1. Proportion of patients able to achieve therapeutic target

    Time frame: 24 hours

  2. Clearance of tobramycin in the burn population

    Time frame: 24 hours

  3. Volume of distribution of tobramycin in the burn population

    Time frame: 24 hours

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Sandra Walker

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2014
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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