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Evaluation Of Linezolid Pk Profile In Burns Patients

Primary Purpose

Burns

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
linezolid
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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.

Full Information

First Posted
November 18, 2005
Last Updated
July 13, 2009
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00255996
Brief Title
Evaluation Of Linezolid Pk Profile In Burns Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
Evaluation of linezolid pk profile in burns patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
linezolid
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75679
Country
France

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5951109&StudyName=Evaluation+Of+Linezolid+Pk+Profil+In+Burns+Patients
Description
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Evaluation Of Linezolid Pk Profile In Burns Patients

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