Population Pharmacokinetics of Linezolid

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.

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Key information

Conditions

Methicillin-Resistant Staphylococcus Aureus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linezolid

Drug

Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers

Other names: Pharmacokinetics of Linezolid

Primary outcomes

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).

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Sep 13, 2010
Registry last updated: Oct 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed