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Evaluation Of Linezolid Pk Profile In Burns Patients

Last updated on December 16, 2017

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Similar Trials

Evaluation Of Linezolid Pk Profile In Burns Patients
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
Evaluation of linezolid pk profile in burns patients
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Burns
Drug: linezolid
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2007
Not Provided

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;
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00255996
A5951109
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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