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

NCT ID: NCT02241941

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Burn Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Daptomycin

Group Type EXPERIMENTAL

Daptomycin

Intervention Type DRUG

Interventions

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Daptomycin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rainer Weber, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Division of Infectious Diseases and Hospital Epidemiology, Universitit Hospital Zurich

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EK-1748

Identifier Type: -

Identifier Source: secondary_id

Dapto-ICU-09

Identifier Type: -

Identifier Source: org_study_id