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

University of Zurich (UZH)

Status and phase: Withdrawn; Phase 4

Conditions: Burn Injury

Treatments: Drug: Daptomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02241941

EK-1748

Dapto-ICU-09

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Daptomycin

Experimental group

Treatment:

Drug: Daptomycin