Evaluation Of Linezolid Pk Profile In Burns Patients - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00255996

Purpose

Evaluation of linezolid pk profile in burns patients

Condition	Intervention	Phase
Burns	Drug: linezolid	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Official Title:	An Open Label Parallel Group Study To Investigate The Pharmacokinetics Of Intravenous Linezolid, An Oxazolidinone, Administered To Healthy Volunteers And Patients With Major Thermal Injuries

Resource links provided by NLM:

MedlinePlus related topics: Burns

Drug Information available for: Linezolid

Further study details as provided by Pfizer:

Primary Outcome Measures:

To assess and compare pharmacokinetic parameters of a single dose 1-hour intravenous linezolid (Zyvox) at 600 mg in patients with major thermal injuries (>40% body area) and in healthy volunteers

Secondary Outcome Measures:

To assess and compare tolerability and safety of a single dose of 600mg IV linezolid administered in patients with major thermal injuries (>40% body area) and in healthy volunteers.

Eligibility

Criteria

Inclusion Criteria:

Subject with a Body Mass Index (BMI) < 30 kg/m². For patient with major thermal injuries, the weight will be collected before the burn ;
Patients with major thermal injuries >40% body area including 3rd degree burns with full thickness burns ;
Patients hospitalized for at least 10 days since their thermal injury occurred ;

Exclusion Criteria:

Contra-indications to use linezolid as mentioned in the SmPC (Summarized Product Characteristics) : hypersensitivity to linezolid use or to any of its components, non-controlled hypertension, phaeochromocytoma, carcinoid syndrome, hyperthyroidism, bipolar disorders, schizoaffective disorders, acute confused state of mind, pregnancy, and breastfeeding ;
Drugs metabolised by monoamine oxydase (MAO) should be evaluated for potential drug-to-drug interaction;
Subject treated by: selective serotonin reuptake inhibitors (Prozac®, Effexor®, Ixel® ), tricyclic antidepressant (Anafranil®, Sinequan®, Surmontil®, Tofranil®), 5HT1 receptor agonists (triptan) direct or indirect sympathomimetic (including adrenergic bronchodilator, pseudoephedrine and phenylpropylamine), vasopressor (adrenaline and noradrenaline), dopaminergic drugs (dopamine, dobutamine), phenetidine or buspirone should be evaluated for potential drug-to-drug interaction;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255996

Locations

France
Pfizer Investigational Site
Paris, France, 75015
Pfizer Investigational Site
Paris, France, 75679
Pfizer Investigational Site
Nantes, France, 44093

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5951109
Study First Received:	November 18, 2005
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00255996 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Linezolid
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010