NCT Number: NCT00255996
Evaluation Of Linezolid Pk Profile In Burns Patients
Evaluation of linezolid pk profile in burns patients
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Notify MeKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Pfizer Investigational Site, Nantes, France
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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;
Treatment and study plan
Primary outcomes
-
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
-
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.
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Lead sponsor
Pfizer
Industry
Registry information
Official study 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
Important dates
- Study start
- 2006
- Study completion
- 2007
- First posted
- Nov 21, 2005
- Registry last updated
- Jul 14, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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