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Evaluation Of Linezolid Pk Profile In Burns Patients

Last updated on November 29, 2019

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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Descriptive Information
Brief Title  ICMJE Evaluation Of Linezolid Pk Profile In Burns Patients
Official Title  ICMJE 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
Brief SummaryEvaluation of linezolid pk profile in burns patients
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Burns
Intervention  ICMJE Drug: linezolid
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2009)
16
Original Enrollment  ICMJE
 (submitted: November 18, 2005)
20
Actual Study Completion Date  ICMJE January 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00255996
Other Study ID Numbers  ICMJE A5951109
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2009

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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