Evaluation of linezolid pk profil in burns patients

Condition	Intervention	Phase
Burns Patient	Drug: linezolid	Phase I

Further study details as provided by Pfizer:

Primary Outcomes: To assess and compare pharmacokinetic parameters of a single dose 1-hour intravenous linezolid (Zyvoxid®) at 600 mg in patients with major thermal injuries (>40% body area) and in healthy volunteers
Secondary Outcomes: 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.
Expected Total Enrollment:  20

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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, pseudoephedrin and phenylpropalamine), vasopressor (adrenaline and noradrenaline), dopaminergic drugs (dopamine, dobutamine), phetidine or buspirone should be evaluated for potential drug-to-drug interaction;

Please refer to this study by ClinicalTrials.gov identifier  NCT00255996

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A5951109
Last Updated:  December 8, 2005
Record first received:  November 18, 2005
ClinicalTrials.gov Identifier:  NCT00255996
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2006-01-10