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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Withdrawn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
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Burn Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 13, 2014
Last Updated
October 27, 2016
Sponsor
University of Zurich
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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Withdrawn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

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

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