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
1 other identifier
interventional
16
1 country
3
Brief Summary
Evaluation of linezolid pk profile in burns patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2006
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedJuly 14, 2009
July 1, 2009
November 18, 2005
July 13, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Subject with a Body Mass Index (BMI) \< 30 kg/m\². 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 ;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (3)
Pfizer Investigational Site
Nantes, 44093, France
Pfizer Investigational Site
Paris, 75015, France
Pfizer Investigational Site
Paris, 75679, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 18, 2005
First Posted
November 21, 2005
Study Start
May 1, 2006
Study Completion
January 1, 2007
Last Updated
July 14, 2009
Record last verified: 2009-07