Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury

• Status: Withdrawn
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Daptomycin

Criteria

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