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Population Pharmacokinetics of Linezolid

Information source: University Hospital, Toulouse
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Methicillin-Resistant Staphylococcus AureuS

Intervention: Linezolid (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital, Toulouse

Official(s) and/or principal investigator(s):
Bernard Georges, PhMD, Principal Investigator, Affiliation: UH Toulouse

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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The first objective of this study is to research the influence of patients' characteristic on the pharmacokinetics of Linezolid.

Secondary outcome: The secondary outcome measure are the verification of the clinical and bactériological efficacies, and to look after the residual concentration

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- In-patient stay in intensive care

- Over 18 years old

- Presenting with MRSA nosocomial pneumonia or bacteraemia with a strain thought to be

sensitive to Linezolid

- Simplified Acute Physiological Score (SAPS) II > 20

- Expected duration of life > 7 days.

Exclusion Criteria:

- History of allergy to linezolid or any of the antibiotics used

- Isolation of MRSA resistant to linezolid

- Lack of seeds

- Pregnancy and lactation

Locations and Contacts

Additional Information

Starting date: November 2007
Last updated: October 22, 2012

Page last updated: August 23, 2015

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