NCT01200654

Population Pharmacokinetics of Linezolid

Population Pharmacokinetics of Linezolid in Intensive Care Units Patients Treated for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Methicillin-Resistant Staphylococcus AureuS

Interventions

Type	Name	Description
DRUG	Linezolid	Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-09-13
• Last updated: 2012-10-23