Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
- Registration Number
- NCT02241941
- Lead Sponsor
- University of Zurich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Daptomycin Daptomycin -
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters of daptomycin up to 30 days
- Secondary Outcome Measures
Name Time Method degree of variability of daptomycin pk parameters in dependency of body surface area burned up to 30 days Correlation of daptomycin plasma concentrations with tissue concentration up to 30 days
Trial Locations
- Locations (1)
University Hospital Zurich
🇨🇭Zurich, Switzerland