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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2016

Interventions

  • Drug: Daptomycin

Arms, Groups and Cohorts

  • Experimental: Daptomycin

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetic parameters of daptomycin
    • Time Frame: up to 30 days

Secondary Measures

  • Correlation of daptomycin plasma concentrations with tissue concentration
    • Time Frame: up to 30 days
  • degree of variability of daptomycin pk parameters in dependency of body surface area burned
    • Time Frame: up to 30 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rainer Weber, MD Professor, Principal Investigator, Division of Infectious Diseases and Hospital Epidemiology, Universitit Hospital Zurich

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