Evaluation Of Linezolid Pk Profile In Burns Patients

Phase 1

Completed

• Conditions: Burns

• Registration Number: NCT00255996
• Lead Sponsor: Pfizer

Brief Summary

Evaluation of linezolid pk profile in burns patients

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-18
• Study First Submitted QC: 2005-11-18
• Study First Posted: 2005-11-21
• Study Start: 2006-05
• Study Completion: 2007-01
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-13
• Last Update Posted: 2009-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇫🇷 Paris, France