Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
Primary Purpose
Burn Injury
Status
Withdrawn
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Daptomycin
Sponsored by
About this trial
This is an interventional diagnostic trial for Burn Injury
Eligibility 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
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Daptomycin
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetic parameters of daptomycin
Secondary Outcome Measures
Correlation of daptomycin plasma concentrations with tissue concentration
degree of variability of daptomycin pk parameters in dependency of body surface area burned
Full Information
NCT ID
NCT02241941
First Posted
September 13, 2014
Last Updated
October 27, 2016
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT02241941
Brief Title
Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
Official Title
Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Assessment of daptomycin concentrations with microdialysis technically not feasible
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daptomycin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Primary Outcome Measure Information:
Title
Pharmacokinetic parameters of daptomycin
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Correlation of daptomycin plasma concentrations with tissue concentration
Time Frame
up to 30 days
Title
degree of variability of daptomycin pk parameters in dependency of body surface area burned
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Weber, MD Professor
Organizational Affiliation
Division of Infectious Diseases and Hospital Epidemiology, Universitit Hospital Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
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