Status:
WITHDRAWN
Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
Lead Sponsor:
University of Zurich
Conditions:
Burn Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02241941
Start Date
September 1 2014
End Date
October 1 2016
Last Update
October 28 2016
Active Locations (1)
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1
University Hospital Zurich
Zurich, Switzerland, 8091