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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 November 2016 |
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Main ID: |
NCT02241941 |
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Date of registration:
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13/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
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Scientific title:
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Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02241941 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 4
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Rainer Weber, MD Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Infectious Diseases and Hospital Epidemiology, Universitit Hospital Zurich |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Burn Injury
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Intervention(s)
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Drug: Daptomycin
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Primary Outcome(s)
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Pharmacokinetic parameters of daptomycin
[Time Frame: up to 30 days]
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Secondary Outcome(s)
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degree of variability of daptomycin pk parameters in dependency of body surface area burned
[Time Frame: up to 30 days]
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Correlation of daptomycin plasma concentrations with tissue concentration
[Time Frame: up to 30 days]
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Secondary ID(s)
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EK-1748
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Dapto-ICU-09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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