BurnsPhase 1/2NCT02269969
Once Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study
A Phase 1/2 study testing Tobramycin in people with Burns and Infection, run by Sandra Walker at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Tobramycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Dec 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Known allergy or adverse reaction to aminoglycoside antibiotics
- Known allergy or adverse reaction to sulfites
- Diagnosis of Parkinson's disease or myasthenia gravis
Trial locations and contacts
1 site in 1 country.
About this 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.
- Being tested
- Tobramycin
- Keywords
- Aminoglycoside, Pharmacokinetics, Once daily dosing
- Medical subject headings
- Burns, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TobramycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Once daily aminoglycoside | Experimental | Once daily dosing of Tobramycin Receives: Drug: Tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients able to achieve therapeutic target
Measured: 24 hours
Clearance of tobramycin in the burn population
Measured: 24 hours
Volume of distribution of tobramycin in the burn population
Measured: 24 hours
Breakpoint in tobramycin clearance based on time post-burn, body burn surface area, inhalation injury score, or percentage of open wounds
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandra Walker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sandra Walker, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269969
- Sponsor's protocol ID
- 183-2014
- Status last verified
- Dec 2015
- First submitted
- 8 Oct 2014
- Last updated
- 14 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study
- ClinicalTrials.gov ID
- NCT02269969
- Acronym / sponsor ID
- 183-2014
- Keywords
- Aminoglycoside, Pharmacokinetics, Once daily dosing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sandra WalkerUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Once daily aminoglycoside | Experimental | Drug: TobramycinOnce daily dosing of Tobramycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Pediatric patients (< 18 years old);
- Pregnant
- Documented history of cochlear or vestibular injury
- Creatinine clearance < 50 ml/min
- Requiring any modality of dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobramycin | Drug | Once daily aminoglycoside |
Primary outcome
Proportion of patients able to achieve therapeutic target
Time frame: 24 hours
Clearance of tobramycin in the burn population
Time frame: 24 hours
Volume of distribution of tobramycin in the burn population
Time frame: 24 hours
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tobramycin in people with Burns and Infection, run by Sandra Walker at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients able to achieve therapeutic target (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.