Burn Injury
Conditions
Brief summary
The purpose of this study is to determine single dose pharmacokinetics of daptomycin consecutively in 10 patients on three different time points after severe burn injury.
Interventions
DRUGDaptomycin
Sponsors
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female of 18 years or older * Second and/or third degree thermal injury * Total body surface area burned ≥ 15% * Hospitalisation in the ICU for burn injured patients of the University Hospital Zürich * Probability of ICU stay of \>14 days * Written informed consent by the patient or in patients unable to be informed or to sign according to section 4.4 of the study protocol
Exclusion criteria
* Evidence of renal failure (Creatinine clearance \<30ml/min) or continuous renal replacement therapy such as continuous hemofiltration * History of muscle disease or skeletal muscle disorder * Creatine-phosphokinase (CPK) ≥ 5 times the upper limit of normal (ULN) * History of hypersensitivity to the drug * Pregnancy * Severe coagulation disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of daptomycin | up to 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of daptomycin plasma concentrations with tissue concentration | up to 30 days |
| degree of variability of daptomycin pk parameters in dependency of body surface area burned | up to 30 days |
Countries
Switzerland
Outcome results
None listed