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

Burn Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02241941
• Other study ID #: Dapto-ICU-09
• Secondary ID: EK-1748
• Status: Withdrawn
• Phase: Phase 4
• First received: September 13, 2014
• Last updated: October 27, 2016
• Start date: September 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Wounds and Injuries

Intervention

Drug:
• Daptomycin

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters of daptomycin		up to 30 days	Yes
Secondary	Correlation of daptomycin plasma concentrations with tissue concentration		up to 30 days	Yes
Secondary	degree of variability of daptomycin pk parameters in dependency of body surface area burned		up to 30 days	Yes