Methicillin-Resistant Staphylococcus AureuS Clinical Trial
Official title:
Population Pharmacokinetics of Linezolid in Intensive Care Units Patients Treated for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections
Linezolid is the first of a new class of antibacterial drugs, the oxazolidinones. It has a
specific inhibitory activity against Gram positive bacteria, including methicillin-resistant
Staphylococcus aureus (MRSA).
Dosage of 600 mg discontinuous administration twice a day was about studies in safety
volunteers. The intensive care units patients, with mechanical ventilation, and with severe
sepsis, represent highly heterogeneous population responsible of hight variability in
pharmacokinetics parameters (augmentation in total volume of distribution, modification in
glomerular filtration) wich can lead to antibiotic inefficacy.
In a first time, this study describe the pharmacokinetics of Linezolid in intensive care
units patients with severe MRSA infection. The aim of this study is to define and validate a
population pharmacokinetic model including the influence of patients' characteristic on the
pharmacokinetics of Linezolid.
The demographic, clinical and biological parameters are collected. Patients receive
Linezolid as 600 mg twice a day during an administration of 60 minutes.
Blood sampling are collected on the second day after beginning of treatment at the following
time : H1, H2, H3, H6 and H12.
The population pharmacokinétics analysis will be carried out using Monolix, a software for
the analysis of nonlinear mixed effects models.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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