Evaluation Of Linezolid Pk Profile In Burns Patients

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00255996
First received: November 18, 2005
Last updated: July 13, 2009
Last verified: July 2009
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00255996     History of Changes
Other Study ID Numbers: A5951109
Study First Received: November 18, 2005
Last Updated: July 13, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014