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
|