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Evaluation Of Linezolid Pk Profile In Burns Patients

Last updated on February 20, 2019

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Study Location
Pfizer Investigational Site
Nantes, , 44093 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Burns
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Subject with a Body Mass Index (BMI) 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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;

NCT00255996
Pfizer
Completed
Evaluation Of Linezolid Pk Profile In Burns Patients

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Burns
NCT00255996
All Genders
18+
Years
Multiple Sites

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1-800-718-1021

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