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Evaluation Of Linezolid Pk Profile In Burns Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00255996
First Posted: November 21, 2005
Last Update Posted: July 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
Evaluation of linezolid pk profile in burns patients

Condition Intervention Phase
Burns Drug: linezolid Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To assess and compare pharmacokinetic parameters of a single dose 1-hour intravenous linezolid (Zyvox) at 600 mg in patients with major thermal injuries (>40% body area) and in healthy volunteers

Secondary Outcome Measures:
  • To assess and compare tolerability and safety of a single dose of 600mg IV linezolid administered in patients with major thermal injuries (>40% body area) and in healthy volunteers.

Enrollment: 16
Study Start Date: May 2006
Study Completion Date: January 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject with a Body Mass Index (BMI) < 30 kg/m&#178;. 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&#174;, Effexor&#174;, Ixel&#174; &#133;), tricyclic antidepressant (Anafranil&#174;, Sinequan&#174;, Surmontil&#174;, Tofranil&#174;), 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;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255996


Locations
France
Pfizer Investigational Site
Nantes, France, 44093
Pfizer Investigational Site
Paris, France, 75015
Pfizer Investigational Site
Paris, France, 75679
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00255996     History of Changes
Other Study ID Numbers: A5951109
First Submitted: November 18, 2005
First Posted: November 21, 2005
Last Update Posted: July 14, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action