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

NCT02269969 | Completed Phase 1

• 1 other identifier: 183-2014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Infection

Keywords

Aminoglycoside; Pharmacokinetics; Once daily dosing

Outcome Measures

Primary Outcomes (5)

• Proportion of patients able to achieve therapeutic target

  24 hours

• Clearance of tobramycin in the burn population

  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

• 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

Study Arms (1)

Once daily aminoglycoside

EXPERIMENTAL

Once daily dosing of Tobramycin

Drug: Tobramycin

Interventions

Tobramycin DRUG

Once daily aminoglycoside

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sandra Walker: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Burns; Infections

Interventions

Tobramycin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 21, 2014
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

CA (1)