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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRSA Infections | Experimental | Methicillin-Resistant Staphylococcus aureus Infections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linezolid | Drug | Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers |
|
| Measure | Description | Time Frame |
|---|---|---|
| The first objective of this study is to research the influence of patients' characteristic on the pharmacokinetics of Linezolid. | 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). | Blood sampling are collected on the second day after begining of treatment at the following time : H1, H2, H3, H6 and H12. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome measure are the verification of the clinical and bactériological efficacies, and to look after the residual concentration | At the 48th hours of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Georges, PhMD | UH Toulouse | Principal Investigator |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |