Evaluation Of Linezolid Pk Profile In Burns Patients

Condition(s) targeted: Burns

Intervention: linezolid (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study

Primary outcome: To assess and compare pharmacokinetic parameters of a single dose 1-hour intravenous linezolid (Zyvoxid®) at 600 mg in patients with major thermal injuries (>40% body area) and in healthy volunteers

Secondary outcome: 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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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;

Pfizer Investigational Site, Paris 75015, France

Pfizer Investigational Site, Paris 75679, France

Pfizer Investigational Site, Nantes 44093, France

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting

Starting date: May 2006
Last updated: January 24, 2008