Population Pharmacokinetics of Linezolid

NCT01200654 | Completed Phase 4

• 1 other identifier: 06 049 02
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Methicillin-Resistant Staphylococcus AureuS

Keywords

Population pharmacokinetics; Linezolid; Monolix; nonlinear mixed effects models

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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

Study Arms (1)

MRSA Infections

EXPERIMENTAL

Methicillin-Resistant Staphylococcus aureus Infections

Drug: Linezolid

Interventions

Linezolid DRUG

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

Also known as: Pharmacokinetics of Linezolid

MRSA Infections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of allergy to linezolid or any of the antibiotics used
• Isolation of MRSA resistant to linezolid
• Lack of seeds
• Pregnancy and lactation

Sponsors & Collaborators

• University Hospital, Toulouse: lead

MeSH Terms

Interventions

Linezolid

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bernard Georges, PhMD

  UH Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 13, 2010
• Study Start: November 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 23, 2012

Record last verified: 2012-10