Evaluation Of Linezolid Pk Profile In Burns Patients

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of linezolid pk profile in burns patients

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Linezolid

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;