Evaluation Of Linezolid Pk Profile In Burns Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00255996
• Date of registration: 18/11/2005
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Evaluation Of Linezolid Pk Profile In Burns Patients
• Scientific 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
• Date of first enrolment: May 2006
• Target sample size: 16
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00255996
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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;



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Burns

Intervention(s)

Drug: linezolid

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

A5951109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors