Population Pharmacokinetics of Linezolid

Methicillin-Resistant Staphylococcus AureuS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200654
• Other study ID #: 06 049 02
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2010
• Last updated: October 22, 2012
• Start date: November 2007
• Est. completion date: August 2010

Study information

• Verified date: October 2012
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Methicillin-Resistant Staphylococcus AureuS
• Staphylococcal Infections

Intervention

Drug:
• Linezolid
Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No