Status:
COMPLETED
Evaluation Of Linezolid Pk Profile In Burns Patients
Lead Sponsor:
Pfizer
Conditions:
Burns
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Evaluation of linezolid pk profile in burns patients
Eligibility Criteria
Inclusion
- Subject with a Body Mass Index (BMI) \< 30 kg/m\². 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
- 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;
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00255996
Start Date
May 1 2006
End Date
January 1 2007
Last Update
July 14 2009
Active Locations (3)
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1
Pfizer Investigational Site
Nantes, France, 44093
2
Pfizer Investigational Site
Paris, France, 75015
3
Pfizer Investigational Site
Paris, France, 75679