Skip to main content
OpenTrials
Completed

NCT Number: NCT00255996

Evaluation Of Linezolid Pk Profile In Burns Patients

Evaluation of linezolid pk profile in burns patients

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Nantes, France

Loading trial locations.

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/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;

Treatment and study plan

Linezolid

Drug

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.

Sponsors and collaborators

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.

Published trials that share one or more normalized conditions with this study.