Population Pharmacokinetics of Linezolid
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|ClinicalTrials.gov Identifier: NCT01200654|
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : October 23, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Methicillin-Resistant Staphylococcus AureuS||Drug: Linezolid||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Population Pharmacokinetics of Linezolid in Intensive Care Units Patients Treated for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
Experimental: MRSA Infections
Methicillin-Resistant Staphylococcus aureus Infections
Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers
Other Name: Pharmacokinetics of Linezolid
- The first objective of this study is to research the influence of patients' characteristic on the pharmacokinetics of Linezolid. [ Time Frame: Blood sampling are collected on the second day after begining of treatment at the following time : H1, H2, H3, H6 and H12. ]The following demographic, clinical and biological parameters were collected as possible covariates: age, gender, bodyweight, height, etiology of incoming, mechanical ventilation, serum creatinine, proteins, Blood Urea Nitrogen (BUN), leukocyte counts, haemoglobin, C-reactive protein (CRP), and simplified acute physiology scores (SAPS I and II).
- The secondary outcome measure are the verification of the clinical and bactériological efficacies, and to look after the residual concentration [ Time Frame: At the 48th hours of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200654
|Principal Investigator:||Bernard Georges, PhMD||UH Toulouse|